FDA Approves Migraine Drug for Children

By Pat Anson, Editor 

Millions of children who suffer from migraine headaches have a new treatment option -- an old drug that's already available to adults. 

The Food and Drug Administration approved Treximet for pediatric patients 12 years of age and older for the treatment of migraine with or without aura. Treximet is the first approved combination prescription drug for migraine to contain sumatriptan and naproxen, a non-steroidal anti-inflammatory drug (NSAID). Sumatriptan is a triptan that works in the brain by reducing vascular inflammation. 

About 20 percent of all pediatric patients 11 years and older suffer from migraine, but treatment options have been limited, compared to adults. 

“Until now, pediatric migraine sufferers have not had the same number of treatment options compared to adults to manage the potentially debilitating effects of acute migraine,” said Merle Lea Diamond, MD, president and managing director of the Diamond Headache Clinic and a consultant to Pernix Therapeutics (NASDAQ: PTX), which developed Treximet. Pernix expects Treximet to be available for pediatric patients in the third quarter of 2015.  

“As many as one out of five teens suffers from migraines, and their burden goes well beyond the pain, as migraines can also adversely affect their social growth and their efforts in school,” said Diamond. 

FDA approval came after a Phase III safety and efficacy study that found Treximet was significantly more effective than placebo in treating migraine in pediatric patients and has a safety profile similar to that of Treximet for adults. It comes with a black box warning of cardiovascular and gastrointestinal risks. 

The FDA approved Treximet for adults in 2008. The FDA set a priority review of Treximet for pediatric patients, in part, on the need for more treatment options for younger migraine sufferers.  

Amgen Migraine Drug 

Meanwhile, Amgen (NASDAQ: AMGN) announced the first results from a Phase II study evaluating the efficacy and safety of AMG 334 for the prevention of episodic migraine.

The  company said the study met its primary goal of reducing monthly mean migraine days compared with placebo.  The data were presented at the International Headache Society in Valencia, Spain.

AMG 334 is a fully human monoclonal antibody under investigation for the prevention of migraine by inhibiting a peptide receptor that is believed to transmit signals that can cause incapacitating pain.  

In the trial, 483 patients who averaged 8.7 migraine days per month prior to the study had their number of migraine days nearly cut in half by taking AMG 334.

"Migraine is a complicated, underdiagnosed neurological condition that has significant impact on the everyday activities of those who live with it, and for the millions of people around the world who are affected by this disease, significant unmet therapeutic need persists," said Sean Harper, MD, executive vice president, Research and Development at Amgen. "We are encouraged by these Phase 2 data, which further validate AMG 334 as a potential preventive treatment for episodic migraine."

Migraine is thought to affect a billion people worldwide and about 31 million Americans adults. It affects three times as many women as men. In addition to headache pain and nausea, migraine can also cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound. About half of people living with migraine are undiagnosed.