The U.S. Food and Drug Administration has set a PDUFA date for January 17 next year when it will decide whether or not to give the drug delivery system approval, according to a company statement. The company resubmitted its Zelrix transdermal patch for approval earlier this year after resolving issues raised in a complete response letter in 2011.
NuPathe has also initiated cost containment measures to help it meets its goals.
Armando Anido, the CEO of the company who replaced Jane Hollingsworth earlier this year, said in a statement that it would also look for a commercial partner.
“We believe this financing, combined with the cost containment measures we expect to implement, will provide the financial resources necessary to fund our operations for approximately one year and, importantly, to obtain approval for NP101,” Anido said.
The announcement reflects comments Anido made to MedCity at the end of July when he joined the company.
“My number one priority is cash. We need to have sufficient resources from a money standpoint to execute the launch of the product.”
The company’s Zelrix transdermal patch transmits sumatriptan with an electrical charge through the skin in a drug-delivery method known as iontophoresis. The delivery method was chosen because nausea is one of the symptoms people with migraine headaches experience, and makes oral medication a challenge.
The Migraine Research Foundation estimates that 39 million people experience migraine headaches.