MedPointe Pharmaceuticals announced that the Food and Drug Administration (FDA) has approved Soma (Carisoprodol) 250 mg as a new recommended dose of Soma (Carisoprodol) for the relief of discomfort associated with acute, painful musculoskeletal conditions, such as backache. Soma (Carisoprodol) 250 mg offers comparable efficacy to the widely prescribed skeletal muscle relaxant SOMA 350 mg with a more favorable tolerability profile, including less drowsiness.

Back pain is the fifth leading reason for patient visits to physicians and ranks among the top ten most costly physical disorders. This ailment is responsible for direct health care expenditures of more than $20 billion annually and as much as $50 billion per year when indirect costs are included.

“The clinical benefits of Soma (Carisoprodol) 250 mg are in line with current treatment strategies for back pain which focus on helping patients to return to normal physical activity as quickly as possible,” said Lee Ralph, M.D., Assistant Clinical Professor, Department of Family and Preventative Medicine, University of California, San Diego, LaJolla; physician partner, San Diego Sports Medicine and Family Health Center; and a lead author and investigator for the Soma (Carisoprodol) 250 mg clinical trials. “I look forward to offering my patients SOMA 250 mg as data indicates that it can help relieve discomfort from acute backache. Further, Soma (Carisoprodol) 250 mg demonstrated efficacy comparable to Soma (Carisoprodol) 350 mg with a more favorable tolerability profile, including less drowsiness.”

“The availability of Soma (Carisoprodol) 250 mg marks a significant milestone in the treatment of acute backache, a common and terribly painful condition which also has a tremendous economic impact on our nation’s health care system,” said Paul R. Edick, President & Chief Executive Officer of MedPointe Pharmaceuticals. “While Soma (Carisoprodol) has a long history in the treatment of discomfort associated with acute, painful musculoskeletal conditions with nearly 50 years on the market, we are pleased to provide a new recommended dose that provides a proven clinical benefit to help relieve the burden of these conditions.”

Clinical Trials Demonstrate Soma (Carisoprodol) 250 mg Efficacy and Favorable Tolerability Profile

FDA approval of Soma (Carisoprodol) 250 mg was based on the results from two randomized, double-blind, placebo-controlled, multi-site parallel group studies (MP502 and MP505) which included more than 1,300 patients aged 18 to 65 who suffered from acute painful muscle spasm of the lower back. Results from both studies showed that Soma (Carisoprodol)250 mg provided significant and rapid relief of back pain compared to placebo (P = 0.0001) with efficacy comparable to Soma (Carisoprodol) 350 mg.

Results from the studies also showed that Soma (Carisoprodol) 250 mg provided efficacy comparable to Soma (Carisoprodol) 350 mg with a more favorable tolerability profile, resulting in fewer discontinuations due to treatment-related adverse events. In the studies, the discontinuation rate due to adverse events for Soma (Carisoprodol) 250 mg was comparable to placebo and lower than that for Soma (Carisoprodol) 350 mg (2% versus 2.7% versus 5.4% respectively). The most common side effects associated with Soma (Carisoprodol) 250 mg in clinical trials included drowsiness (13%), dizziness (8%) and headache (5%). The most common side effects for Soma (Carisoprodol) 350 mg included drowsiness (17%), dizziness (7%) and headache (3%).

This new recommended dose of Soma (Carisoprodol) is 250 mg three times a day and at bedtime.

Important Information

Soma (Carisoprodol) is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Soma (Carisoprodol) should be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration.

Since the effects of Soma (Carisoprodol) and CNS depressants (including alcohol) or psychotropic drugs may be additive, appropriate caution should be exercised with patients who take more than one of these agents simultaneously. In postmarketing experience with Soma (Carisoprodol), cases of dependence, withdrawal, and abuse have been reported with prolonged use. SOMA should be used with caution in addiction-prone patients. There have been postmarketing reports of seizures in Soma (Carisoprodol)treated patients with most cases having occurred in the setting of multiple drug overdoses.

Most common side effects include drowsiness, dizziness and headache.

Osteoporosis often causes very painful fractures, which can take many months to heal. In many cases, the pain starts to go away as the fracture heals. Most new fractures heal in approximately 3 months. Pain that continues after that is generally considered chronic pain. One cause of chronic pain is vertebral fractures. When a vertebra breaks, some people have no pain, while others have intense pain and muscle spasms that last long after the fracture has healed.

Pain is the body’s way of responding to an injury. When a bone breaks, nerves send pain messages through the spinal cord to the brain, where they are interpreted. Your response to pain is determined by many factors, including your emotional outlook. For example, depression seems to increase a person’s perception of pain and decrease her or his ability to cope with it. Often, treating the depression treats the pain as well.

Chronic pain is pain that lasts beyond the expected time for healing and interferes with normal life. The injury has healed, but the pain continues. The pain message may be triggered by muscle tension, stiffness, weakness, or spasms. Whatever the cause of chronic pain, feelings of frustration, anger, and fear can make the pain more intense. Chronic pain can affect all areas of your life and should be taken seriously.

Coping Strategies: Physical Methods of Pain Management
Heat and ice: Heat, in the form of warm showers or hot packs, can relieve chronic pain or stiff muscles. Cold packs or ice packs provide pain relief by numbing the pain-sensing nerves in the affected area. Cold also helps reduce swelling and inflammation. Depending on which feels better, apply heat or cold for 15 to 20 minutes at a time to the area where you feel the pain. To protect your skin, place a towel between your skin and the source of the cold or heat. Some simple ways to make heat and ice packs are listed below:

Warm towels or hot packs in the microwave for a quick source of heat. (Handle carefully.)
Make instant cold packs from frozen juice cans or bags of frozen vegetables.
Freeze a plastic, resealable bag filled with water to make a good ice bag.
Transcutaneous Electrical Nerve Stimulation (TENS): A TENS machine is a small device that sends electrical impulses to certain parts of the body to block pain signals. Two electrodes are placed on the body where you are experiencing pain. The electrical current that is produced is very mild, but it can prevent pain messages from being transmitted to the brain. Pain relief can last for several hours. Some people may use a small, portable TENS unit that hooks onto a belt for more continuous relief. TENS machines should only be used under the supervision of a physician or physical therapist. They can be purchased or rented from hospital supply or surgical supply houses; however, a prescription is necessary for insurance reimbursement.

Braces and supports: Spinal supports or braces reduce pain and inflammation by restricting movement. Following a vertebral fracture, a back brace or support will relieve pain and allow you to resume normal activities while the fracture heals. However, continuous use of a back support can weaken back muscles. For this reason, exercises to strengthen the muscles in the back should be started as soon as possible.

Exercise and physical therapy: Prolonged inactivity increases weakness and causes loss of muscle mass and strength. A regular exercise program and physical therapy can help you regain strength, energy, and a more positive outlook on life. Because exercise raises the body’s level of endorphins – or natural pain killers produced by the brain – it will relieve pain somewhat. Exercise also relieves tension, increases flexibility, strengthens muscles, and reduces fatigue.

A physical therapist can help you reorganize your home or work environment to avoid further injuries. Physical therapists also teach proper posture and exercises to strengthen the back and abdominal muscles without injuring a weakened spine. Water therapy in a pool, for example, is one of the best exercise techniques for gently improving back muscle strength and reducing pain.

Acupuncture and acupressure: Acupuncture is the use of special needles that are inserted into the body at certain points. These needles stimulate nerve endings and cause the brain to release endorphins. It may take several acupuncture sessions before the pain is relieved. Acupuncture has been used for centuries in China and other parts of Asia to treat many types of pain.

Acupressure is direct pressure applied to areas that trigger pain. This technique can be self-administered after training with an instructor.

Massage therapy: Massage therapy can be a light, slow, circular motion with the fingertips or a deep, kneading motion that moves from the center of the body outward toward the fingers or toes. Massage relieves pain, relaxes stiff muscles, and smoothes out muscle knots by increasing the blood supply to the affected area and warming it. The person doing the massage uses oil or powder so that her or his hands slide smoothly over the skin. Massage can also include gentle pressure over the affected areas or hard pressure over trigger points in muscle knots. Note: Deep muscle massage should not be done near the spine of a person who has spinal osteoporosis. Light, circular massage with fingers or the palm of the hand is best in this case.

Coping Strategies: Psychological Methods of Pain Management
Relaxation training: Relaxation involves concentration and slow, deep breathing to release tension from muscles and relieve pain. Learning to relax takes practice, but relaxation training can focus attention away from pain and release tension from all muscles. Relaxation tapes are widely available to help you learn these skills.

Biofeedback: Biofeedback is taught by a professional who uses special machines to help you learn to control bodily functions, such as heart rate and muscle tension. As you learn to release muscle tension, the machine immediately indicates success. Biofeedback can be used to reinforce relaxation training. Once the technique is mastered, it can be practiced without the use of the machine.

Visual imagery and distraction: Imagery involves concentrating on mental pictures of pleasant scenes or events or mentally repeating positive words or phrases to reduce pain. Tapes are also available to help you learn visual imagery skills.

Distraction techniques focus your attention away from negative or painful images to positive mental thoughts. This may include activities as simple as watching television or a favorite movie, reading a book or listening to a book on tape, listening to music, or talking to a friend.

Hypnosis: Hypnosis can be used in two ways to reduce your perception of pain. Some people are hypnotized by a therapist and given a post-hypnotic suggestion that reduces the pain they feel. Others are taught self-hypnosis and can hypnotize themselves when pain interrupts their ability to function. Self-hypnosis is a form of relaxation training.

Individual, group, or family therapy: These forms of psychotherapy may be useful for those whose pain has not responded to physical methods. People who suffer from chronic pain often experience emotional stress and depression. Therapy can help you cope with these feelings, making it easier to manage your pain.

Coping Strategies: Medication for Pain Management
Medications are the most popular way to manage pain. Commonly used medications include aspirin, acetaminophen, and ibuprofen. Although these are probably the safest pain relievers available, they sometimes cause stomach irritation and bleeding.

Narcotic drugs may be prescribed for short-term acute pain. These drugs should not be used for long periods because they are addictive and can affect your ability to think clearly. They also have other side effects, such as constipation.

Many people with persistent pain that has not responded to other forms of pain relief are treated with antidepressant medication. These drugs may work in a different way when used for treatment of unyielding pain. The body’s internal pain suppression system may depend upon the concentrations of various chemicals in the brain. These concentrations are increased by the use of antidepressants.

The above-mentioned methods of pain management are used in various hospitals and clinics across the country. If you have chronic pain that has not responded to treatment, you should consult your physician for a referral to a physical therapist or a clinic specializing in pain management.

Pain is the body’s way of responding to an injury. When a bone breaks, nerves send pain messages through the spinal cord to the brain, where they are interpreted. Your response to pain is determined by many factors, including your emotional outlook. For example, depression seems to increase a person’s perception of pain and decrease her or his ability to cope with it. Often, treating the depression treats the pain as well.

Chronic pain is pain that lasts beyond the expected time for healing and interferes with normal life. The injury has healed, but the pain continues. The pain message may be triggered by muscle tension, stiffness, weakness, or spasms. Whatever the cause of chronic pain, feelings of frustration, anger, and fear can make the pain more intense. Chronic pain can affect all areas of your life and should be taken seriously.

The following information provides those who have chronic pain with an overview of different options for pain management. If you have chronic pain and need help managing it, you may wish to discuss these options with your doctor.

Coping Strategies: Physical Methods of Pain Management
Heat and ice: Heat, in the form of warm showers or hot packs, can relieve chronic pain or stiff muscles. Cold packs or ice packs provide pain relief by numbing the pain-sensing nerves in the affected area. Cold also helps reduce swelling and inflammation. Depending on which feels better, apply heat or cold for 15 to 20 minutes at a time to the area where you feel the pain. To protect your skin, place a towel between your skin and the source of the cold or heat. Some simple ways to make heat and ice packs are listed below:

Warm towels or hot packs in the microwave for a quick source of heat. (Handle carefully.)
Make instant cold packs from frozen juice cans or bags of frozen vegetables.
Freeze a plastic, resealable bag filled with water to make a good ice bag.
Transcutaneous Electrical Nerve Stimulation (TENS): A TENS machine is a small device that sends electrical impulses to certain parts of the body to block pain signals. Two electrodes are placed on the body where you are experiencing pain. The electrical current that is produced is very mild, but it can prevent pain messages from being transmitted to the brain. Pain relief can last for several hours. Some people may use a small, portable TENS unit that hooks onto a belt for more continuous relief. TENS machines should only be used under the supervision of a physician or physical therapist. They can be purchased or rented from hospital supply or surgical supply houses; however, a prescription is necessary for insurance reimbursement.

Braces and supports: Spinal supports or braces reduce pain and inflammation by restricting movement. Following a vertebral fracture, a back brace or support will relieve pain and allow you to resume normal activities while the fracture heals. However, continuous use of a back support can weaken back muscles. For this reason, exercises to strengthen the muscles in the back should be started as soon as possible.

Exercise and physical therapy: Prolonged inactivity increases weakness and causes loss of muscle mass and strength. A regular exercise program and physical therapy can help you regain strength, energy, and a more positive outlook on life. Because exercise raises the body’s level of endorphins – or natural pain killers produced by the brain – it will relieve pain somewhat. Exercise also relieves tension, increases flexibility, strengthens muscles, and reduces fatigue.

A physical therapist can help you reorganize your home or work environment to avoid further injuries. Physical therapists also teach proper posture and exercises to strengthen the back and abdominal muscles without injuring a weakened spine. Water therapy in a pool, for example, is one of the best exercise techniques for gently improving back muscle strength and reducing pain.

Acupuncture and acupressure: Acupuncture is the use of special needles that are inserted into the body at certain points. These needles stimulate nerve endings and cause the brain to release endorphins. It may take several acupuncture sessions before the pain is relieved. Acupuncture has been used for centuries in China and other parts of Asia to treat many types of pain.

Acupressure is direct pressure applied to areas that trigger pain. This technique can be self-administered after training with an instructor.

Massage therapy: Massage therapy can be a light, slow, circular motion with the fingertips or a deep, kneading motion that moves from the center of the body outward toward the fingers or toes. Massage relieves pain, relaxes stiff muscles, and smoothes out muscle knots by increasing the blood supply to the affected area and warming it. The person doing the massage uses oil or powder so that her or his hands slide smoothly over the skin. Massage can also include gentle pressure over the affected areas or hard pressure over trigger points in muscle knots. Note: Deep muscle massage should not be done near the spine of a person who has spinal osteoporosis. Light, circular massage with fingers or the palm of the hand is best in this case.

Coping Strategies: Psychological Methods of Pain Management
Relaxation training: Relaxation involves concentration and slow, deep breathing to release tension from muscles and relieve pain. Learning to relax takes practice, but relaxation training can focus attention away from pain and release tension from all muscles. Relaxation tapes are widely available to help you learn these skills.

Biofeedback: Biofeedback is taught by a professional who uses special machines to help you learn to control bodily functions, such as heart rate and muscle tension. As you learn to release muscle tension, the machine immediately indicates success. Biofeedback can be used to reinforce relaxation training. Once the technique is mastered, it can be practiced without the use of the machine.

Visual imagery and distraction: Imagery involves concentrating on mental pictures of pleasant scenes or events or mentally repeating positive words or phrases to reduce pain. Tapes are also available to help you learn visual imagery skills.

Distraction techniques focus your attention away from negative or painful images to positive mental thoughts. This may include activities as simple as watching television or a favorite movie, reading a book or listening to a book on tape, listening to music, or talking to a friend.

Hypnosis: Hypnosis can be used in two ways to reduce your perception of pain. Some people are hypnotized by a therapist and given a post-hypnotic suggestion that reduces the pain they feel. Others are taught self-hypnosis and can hypnotize themselves when pain interrupts their ability to function. Self-hypnosis is a form of relaxation training.

Individual, group, or family therapy: These forms of psychotherapy may be useful for those whose pain has not responded to physical methods. People who suffer from chronic pain often experience emotional stress and depression. Therapy can help you cope with these feelings, making it easier to manage your pain.

Coping Strategies: Medication for Pain Management
Medications are the most popular way to manage pain. Commonly used medications include aspirin, acetaminophen, and ibuprofen. Although these are probably the safest pain relievers available, they sometimes cause stomach irritation and bleeding.

Narcotic drugs may be prescribed for short-term acute pain. These drugs should not be used for long periods because they are addictive and can affect your ability to think clearly. They also have other side effects, such as constipation.

Many people with persistent pain that has not responded to other forms of pain relief are treated with antidepressant medication. These drugs may work in a different way when used for treatment of unyielding pain. The body’s internal pain suppression system may depend upon the concentrations of various chemicals in the brain. These concentrations are increased by the use of antidepressants.

Back pain is an all-too-familiar problem that can range from a dull, constant ache to a sudden, sharp pain that leaves you incapacitated. It can come on suddenly – from an accident, a fall, or lifting something too heavy – or it can develop slowly, perhaps as the result of age-related changes to the spine. Regardless of how it happens or how it feels, you know it when you have it.

Age: The first attack of low back pain typically occurs between the ages of 30 and 40. Back pain becomes more common with age.

Fitness level: Back pain is more common among people who are not physically fit. Weak back and abdominal muscles may not properly support the spine. “Weekend warriors” – people who go out and exercise a lot after being inactive all week – are more likely to suffer painful back injuries than people who make moderate physical activity a daily habit. Studies show that low-impact aerobic exercise is good for the discs that cushion the vertebrae, the individual bones that make up the spine.

Diet: A diet high in calories and fat, combined with an inactive lifestyle, can lead to obesity, which can put stress on the back.

Heredity: Some causes of back pain, including disc disease, may have a genetic component.

The presence of other diseases: Many diseases can cause or contribute to back pain. These include various forms of arthritis, such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and cancers elsewhere in the body that may spread to the spine.

Occupational risk factors: Having a job that requires heavy lifting, pushing, or pulling, particularly when this involves twisting or vibrating the spine, can lead to injury and back pain. An inactive job or a desk job may also lead to or contribute to pain, especially if you have poor posture or sit all day in an uncomfortable chair.

Cigarette smoking: Although smoking may not directly cause back pain, it increases your risk of developing low back pain and low back pain with sciatica. (Sciatica is back pain that radiates to the hip and/or leg due to pressure on a nerve.) For example, smoking may lead to pain by blocking your body’s ability to deliver nutrients to the discs of the lower back. Or, repeated coughing due to heavy smoking may cause back pain. It is also possible that smokers are just less physically fit or less healthy than nonsmokers, which increases the likelihood that they will develop back pain. Furthermore, smoking can slow healing, prolonging pain for people who have had back injuries, back surgery, or broken bones.
Back Pain Causes:
Mechanical problems: A mechanical problem is a problem with the way your spine moves or the way you feel when you move your spine in certain ways. Perhaps the most common mechanical cause of back pain is a condition called intervertebral disc degeneration, which simply means that the discs located between the vertebrae of the spine are breaking down with age. As they deteriorate, they lose their cushioning ability. This problem can lead to pain if the back is stressed. Other mechanical causes of back pain include spasms, muscle tension, and ruptured discs, which are also called herniated discs.

Injuries: Spine injuries such as sprains and fractures can cause either short-lived or chronic pain. Sprains are tears in the ligaments that support the spine, and they can occur from twisting or lifting improperly. Fractured vertebrae are often the result of osteoporosis, a condition that causes weak, porous bones. Less commonly, back pain may be caused by more severe injuries that result from accidents and falls.

Acquired conditions and diseases: Many medical problems can cause or contribute to back pain. They include scoliosis, which causes curvature of the spine and does not usually cause pain until mid-life; spondylolisthesis; various forms of arthritis, including osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis; and spinal stenosis, a narrowing of the spinal column that puts pressure on the spinal cord and nerves. While osteoporosis itself is not painful, it can lead to painful fractures of the vertebrae. Other causes of back pain include pregnancy; kidney stones or infections; endometriosis, which is the buildup of uterine tissue in places outside the uterus; and fibromyalgia, which causes fatigue and widespread muscle pain.

Infections and tumors: Although they are not common causes of back pain, infections can cause pain when they involve the vertebrae, a condition called osteomyelitis, or when they involve the discs that cushion the vertebrae, which is called discitis. Tumors, too, are relatively rare causes of back pain. Occasionally, tumors begin in the back, but more often they appear in the back as a result of cancer that has spread from elsewhere in the body.

There are 2 types of pain: acute and chronic. Acute pain doesn’t last long and usually goes away as your body heals. Chronic pain lasts at least 6 months after your body has healed. Sometimes, when people have chronic pain they don’t know what is causing it. Along with discomfort, chronic pain can cause low self-esteem, depression and anger, and it can interfere with your daily activities.

Treatment of chronic pain usually involves medicines and therapy. Medicines used for chronic pain include pain relievers, antidepressants and anticonvulsants. Different types of medicines help people with different types of pain. You usually use long-acting medicines for constant pain. Short-acting medicines treat pain that comes and goes.

Several types of therapy can help ease your pain. Physical therapy (such as stretching and strengthening activities) and low-impact exercise (such as walking, swimming or biking) can help reduce the pain. However, exercising too much or not at all can hurt chronic pain patients. Occupational therapy teaches you how to pace yourself and how to do ordinary tasks differently so you won’t hurt yourself. Behavioral therapy can reduce your pain through methods (such as meditation and yoga) that help you relax. It can also help decrease stress.

Lifestyle changes are also an important part of treatment for chronic pain. Getting regular sleep at night and not taking daytime naps should help. Stopping smoking helps, too, because the nicotine in cigarettes can make some medicines less effective. Smokers also have more pain than nonsmokers.

Most pain treatments will not take away all of your pain. Instead, treatment should reduce how much pain you have and how often it occurs. Talk to your doctor to learn how to best control your pain.
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What should I tell my doctor about my pain?
Telling your doctor about your pain will help him or her find the right treatment for you. Tell your doctor where the pain is, how bad it is and how often your pain occurs. Also talk about what makes the pain better or worse.

Your doctor may review other health problems (such as arthritis, breathing problems and heart conditions) you may have because these may keep you from doing some types of therapy. Your doctor may also ask if you have had any problems with sleep, mood or anxiety.

Arthritis pain is caused by several factors, such as:

Inflammation, the process that causes the redness and swelling in your joints;
Damage to joint tissues, which results from the disease process or from stress, injury or pressure on the joints;
Fatigue that results from the disease process, which can make your pain seem worse and harder to handle;
Depression or stress, which results from limited movement or no longer doing activities you enjoy. You can get caught in a cycle of pain, limited/lost abilities, stress and depression that makes managing pain and arthritis seem more difficult.
Different Reactions to Pain
People react differently to pain for several reasons. Physical factors include the sensitivity of your nervous system and the severity of your arthritis. Emotional and social factors include your fears and anxieties about pain, previous experiences with pain, energy level, attitude about your condition and the way people around you react to pain.

Many people with arthritis have found that by learning and practicing pain management skills, they can reduce their pain.

Long-lasting pain, like the kind that accompanies arthritis or fibromyalgia, is different. While it tells you that something is wrong, it often isn’t as easy to relieve. Managing this type of pain is essential to enhance your quality of life and sense of well-being.

Pain Factors
What can make your pain feel worse?

Increased disease activity
Stress
Overdoing physical activity
Focusing on pain
Fatigue
Anxiety
Depression
What can block pain signals?

Positive attitude and pleasant thoughts
Appropriate exercise
Relaxation
Medications
Massage
Distraction
Topical pain relievers
Humor
Heat and cold treatments