A new approach
to delivering migraine medication

Migraine Patch With Biodegradable Implant Aces Phase III Trials

August 13, 2009
by Lynn Shapiro, Writer
Privately held NuPathe Inc's migraine patch was successful in Phase III clinical trials. If approved by the FDA, it would provide a new way for migraine suffers to get relief from throbbing headaches and nausea without taking pills.

The company's patch, called Zelrix, contains the migraine drug sumatriptan, the leading prescription migraine medication, Jane Hollingsworth, co-founder and CEO of NuPathe, told DOTmed News. Hollingsworth founded NuPathe in 2005 with Terri Sebree, who is the company's president.

Sumatriptan, the active ingredient in Zelrix, was originally developed by GlaxoSmithKline and marketed under the brand name Imitrex.

"Zelrix was designed to overcome key barriers to successful treatment of migraine, including nausea, side effects from oral medications, and inconsistent drug absorption," Hollingsworth says.

She says the patch showed a "statistically significant" improvement in 530 patients after two hours, in pain, nausea, and sensitivity to light and sound, compared to patients given a placebo.

While it is beneficial for patients to have their migraine medicine delivered transdermally, she says, "prior to Zelrix no one had been able to solve the significant technical challenges of developing a patch for this condition." Scientists at the Conshohocken, PA-based company were able to overcome these hurdles and produce an effective product, Hollingsworth says.

Iontophoretic Technology

The technology that makes the patch possible is NuPathe's proprietary technology, dubbed SmartRelief. SmartRelief is an iontophoretic technology that uses a very low level electrical current to deliver medication through the skin, Hollingsworth explains.

She says the drug would bring fast relief to migraine sufferers and would be particularly helpful to those with migraines that are accompanied by nausea, which frequently occurs in some 55 percent of migraine patients.

"With these positive late stage trial results, NuPathe is planning to file for FDA approval in 2010," Hollingsworth says.

A Marketing Partner?

Nupathe's CEO says she doesn't yet know whether her start-up will market the patch using its own marketing team, or whether she will partner with a larger drug company with a substantial marketing arm.

"If approved, the Zelrix patch would be sold to neurologists, headache specialists and primary care physicians, a huge market for a small company such as ours to undertake," Hollingsworth says. She tells DOTmed she hasn't yet decided whether to go it alone or look for a partner and is considering both scenarios.

Migraine drugs sales are about $2.5 billion a year, so the patch is a potential blockbuster.

IPO in the Offing?

Wall Street is paying increasing attention to NuPathe, now that the company has successfully completed its Phase III trial for the first medicine of its kind, and Hollingsworth is considering taking the company public, "if and when the time is right," she says, to give NuPathe more liquidity. Currently, the company is being funded with venture capital. To date, NuPathe has raised approximately $50 million from leading health care venture capitalists.

"The economic climate isn't right for a small, development stage biotechnology company to access the public markets through an IPO," she says. "But we'll certainly consider taking NuPathe public in the next couple of years, as the economy improves and NuPathe grows."

Parkinson's Product

She says that NuPathe--dedicated to treating central nervous system disorders--also has a Parkinson's disease product in its pipeline. This product delivers a dopamine agonist over a three-month period using NuPathe's biodegradable implant technology. Hollingsworth says she can't disclose which drug the PD device will deliver just yet.

Approximately 30 million Americans have migraines, according to the National Headache Foundation.

Source: NuPathe