FDA approves Botox to treat chronic migraine

The U.S. Food and Drug Administration today (October 15) approved Botox injection (onabotulinumtoxinA) to prevent headaches in adult patients with chronic migraine. Chronic migraine is defined as having a history of migraine and experiencing a headache on most days of the month.

“Chronic migraine is one of the most disabling forms of headache,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Patients with chronic migraine experience a headache more than 14 days of the month. This condition can greatly affect family, work, and social life, so it is important to have a variety of effective treatment options available.”

Migraine headaches are described as an intense pulsing or throbbing pain in one area of the head. The headaches are often accompanied by nausea, vomiting, and sensitivity to light and sound. Migraine is three times more common in women than in men. Migraine usually begins with intermittent headache attacks 14 days or fewer each month (episodic migraine), but some patients go on to develop the more disabling chronic migraine.

To treat chronic migraines, Botox is given approximately every 12 weeks as multiple injections around the head and neck to try to dull future headache symptoms. Botox has not been shown to work for the treatment of migraine headaches that occur 14 days or less per month, or for other forms of headache. It is important that patients discuss with their physician whether Botox is appropriate for them.

The most common adverse reactions reported by patients being treated for chronic migraine were neck pain and headache.

OnabotulinumtoxinA, marketed as Botox and Botox Cosmetic, has a boxed warning that says the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism. Those symptoms include swallowing and breathing difficulties that can be life-threatening. There has not been a confirmed serious case of spread of toxin effect when Botox has been used at the recommended dose to treat chronic migraine, severe underarm sweating, blepharospasm, or strabismus, or when Botox Cosmetic has been used at the recommended dose to improve frown lines.


Botox is manufactured by Allergan Inc. of Irvine, Calif.

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FDA Approves Cambia™ for Migraine

(BUSINESS WIRE)--Kowa Pharmaceuticals America, Inc. (KPA), a privately-held specialty pharmaceutical company headquartered in Montgomery, AL, announced today that the U.S. Food and Drug Administration (FDA) has approved Cambia™, a diclofenac-based non-steroidal anti-inflammatory drug (“NSAID”) combined with potassium bicarbonate, for the treatment of acute migraine with or without aura in adults.

Cambia™, formulated with KPA’s patented Dynamic Buffering Technology (DBT), was specifically developed to address widespread unmet needs among patients by offering fast and effective relief of migraine pain. In randomized clinical trials, Cambia™ was shown to be effective not only in migraine pain, but also in treating photophobia (sensitivity to light), phonophobia (sensitivity to sound), and nausea commonly associated with migraine attacks. Cambia™ was also shown to provide statistically significant onset of relief of migraine pain within 15 to 30 minutes.

“The approval is the culmination of over three years of effort from our partners at Applied Pharma Research and the internal team at Kowa,” said William Maichle, Chief Operating Officer of Kowa Pharmaceuticals America, Inc. “Patients and physicians consistently mention rapid pain relief as most important when asked about primary attributes of a migraine medication. We believe Cambia™ addresses these needs and will be a valuable addition to physicians’ migraine armamentarium.”

KPA obtained exclusive U.S. and Canadian marketing rights for Cambia™ from Applied Pharma Research (APR), a Swiss drug delivery and drug development company, in 2005. The product is currently marketed by Novartis Pharma AG, via a license from APR, under the trademarks Voltfast or Catafast in several European countries. KPA and APR have been granted patents that cover Cambia™ through 2026. KPA and APR are currently in the final stages of negotiations with a marketing partner and expect Cambia™ to launch in 4th quarter 2009.

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Mayo Clinic Proceedings:The Evolution of Migraine from Episodic Headache to Chronic Disorder

Patients living with migraine have strong reason for new optimism concerning a positive future. Two review articles and an accompanying editorial, "The Future of Migraine: Beyond Just Another Pill," in the current issue of Mayo Clinic Proceedings, are the basis for an ironic premise.

"Migraine is a potentially chronic, progressive disease that substantially affects patients, families, workplaces, and society," according to the editorial written by Roger Cady, M.D., of the Headache Care Center in Springfield, Mo. "Ironically, this is the springboard for renewed optimism of a more positive future for patients living with migraine."

Traditionally, Dr. Cady explains, migraine has been considered a pain disorder involving separate or even sporadic episodes. Now, the condition is defined as an all-encompassing and progressive disease that negatively affects all aspects of an individual's life. Migraine can erode quality of life during what should be a person's most productive years, according to Dr. Cady. Because migraine patients' quality of life has not improved at a pace with medical advances, research is addressing the overall severity and potential progressive nature of migraine, especially migraine episodes as a forerunner of chronic migraine.

According to the three articles, these new insights and understandings are requiring professionals to explore well beyond traditional migraine management. "Understanding migraine as a potentially chronic disease mandates a collaborative health care model with patients and health care professionals working in a partnership toward common therapeutic goals," writes Dr. Cady, specifically intervention and prevention.

Physicians and patients must be encouraged to be partners, he says, and evaluation must go far beyond the physician just asking, "How are your migraines?" The models must include an invitation to comprehend and address all migraine-related health issues facing patients, Dr. Cady writes. In addition, understanding the evolutionary "stages" of migraine from sporadic to persistent offers an opportunity to develop new therapies that individualize and personalize care.

In the future, successful management of migraine will ideally be measured not by stopping an attack but by overall disease management and prevention, according to the researchers.

This new understanding of migraine as a chronic disease offers many challenges and rewards, according to Dr. Cady. "Today, the focus of care is rapidly changing from the event of the migraine to the patient with migraine," he notes. These changes present great promise for patients and health care professionals alike, representing assurances of a better future for patients with migraine, concludes Dr. Cady.

A peer-reviewed journal, Mayo Clinic Proceedings publishes original articles and reviews dealing with clinical and laboratory medicine, clinical research, basic science research and clinical epidemiology. Mayo Clinic Proceedings is published monthly by Mayo Foundation for Medical Education and Research as part of its commitment to the medical education of physicians. The journal has been published for more than 80 years and has a circulation of 130,000 nationally and internationally. Articles are available online at www.mayoclinicproceedings.com/.
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FDA Approves First Generic Divalproex Sodium to Treat Seizures, Migraine Headaches and Bipolar Disorder

The U.S. Food and Drug Administration today approved the first generic versions of Depakote delayed-release tablets (divalproex sodium). Depakote is approved by the FDA for the treatment of seizures, bipolar disorder and migraine headaches.

"Generic drugs undergo a rigorous scientific review to ensure that they will provide the patient with the same amount of high quality, safe and effective drug as the name brand product," said Gary J. Buehler, director of the FDA's Office of Generic Drugs. "This approval provides an additional treatment option for patients who suffer from epilepsy, bipolar disorder and migraines."

Generic divalproex sodium will have the same safety warnings as Depakote, including a Boxed Warning that cautions about the risk of liver damage (hepatotoxicity), including fatalities, and pancreatitis, or an inflamed pancreas, including fatal cases. The Boxed Warning also highlights the risk of birth defects (teratogenicity), including neural tube defects.

The following firms have received approval to market divalproex sodium delayed-release tablets: Sun Pharmaceutical Industries Ltd., Mumbai, India; Genpharm Inc., Ontario, Canada; Nu-Pharm Inc., Ontario, Canada; Upsher-Smith Laboratories, Maple Grove, Minn.; Sandoz Inc., Broomfield, Colo.; TEVA Pharmaceuticals USA, North Wales, Penn.; Dr. Reddy’s Laboratories, Hyderabad, India; and Lupin Limited, Mumbai, India.