Topamax

Also Known As: Topamax, Topiramate

Topiramate (brand name Topamax) is an anticonvulsant (antiepilepsy) drug. It was originally produced by Ortho-McNeil Neurologics and Noramco, Inc., both divisions of the Johnson & Johnson Corporation. This medication was discovered in 1979 by Bruce E. Maryanoff and Joseph F. Gardocki during their research work at McNeil Pharmaceutical. Generic versions are available in Canada and these were approved by the Food and Drug Administration (FDA) in September 2006. Mylan Pharmaceuticals was recently granted final approval for generic topiramate 25, 100, and 200 mg tablets and sprinkle capsules by the FDA for sale in the United States. 50 mg tablets were granted tentative approval. The last patent for topiramate in the U.S. was for pediatric use; this patent expired on February 28, 2009.

Topiramate is used to treat epilepsy in children and adults, and it was originally used as an anticonvulsant. In children, it is indicated for the treatment of Lennox-Gastaut syndrome, a disorder that causes seizures and developmental delay. It is also Food and Drug Administration (FDA) approved for, and most frequently prescribed for, the prevention of migraines. Psychiatrists have used topiramate to treat bipolar disorder,[6] and they sometimes use topiramate to augment psychotropics, or to counteract the weight gain associated with numerous antidepressants. In 2006, a Cochrane review concluded that there is insufficient evidence on which to base any recommendations regarding the use of topiramate in any phase of bipolar illness.[7] However, a more recent Cochrane review, published in 2010, concluded that there was evidence for the efficacy of topiramate in the treatment of symptoms of borderline personality disorder, including mood instability. [8]

This drug has been investigated for use in treating alcoholism[9][10] and obesity,[11][12] especially to reduce binge eating.[13][14]

This drug is also widely used to treat migraines due to the effect it has on the blood vessels in the brain. It is used as a preventative for atypical migraine sufferers. It widens the blood vessels in the brain which become restricted by increased serotonin levels. It has been found to be increasingly effective for migraine sufferers with very few side effects.

The drug is also used in clinical trials to treat post traumatic stress disorder.[15] A pilot study suggested that topiramate is effective against infantile spasms.[16] Another study recommends topiramate as an effective treatment in the prevention of periventricular leukomalacia in preterm infants after an hypoxic-ischemic injury.[17]

Other

Recent clinical reports indicate that it may have mood stabilizing properties.[18] Other off-label and investigational uses of topiramate include the treatment of essential tremor, bulimia nervosa,[19] obsessive-compulsive disorder, alcoholism,[10] smoking cessation,[20] idiopathic intracranial hypertension,[21] neuropathic pain,[22] cluster headache,[23] migraine headache, cocaine dependence, and Borderline Personality Disorder. [24] [25] Topiramate is also being studied with a mixture of phentermine to form a drug called Qnexa for the treatment of obesity.

On May 21, 2010, Ortho-McNeil pled guilty and was fined $6.14 million by the FDA for promoting Topamax to treat psychiatric disorders, without applying for any Federal government approval. Also, there was no data from any well-controlled clinical trial to demonstrate that Topamax was safe and/or effective to treat any psychiatric conditions at all.[26]

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