Laura Perryman expected her medical company, Stimwave Technologies, would have to wait several years for its painkilling device to win U.S. approval as a treatment for chronic migraines.
She now thinks it could be done in months, thanks to a new initiative by the U.S. Food and Drug Administration to use medical device-based treatments, diagnostic tests, and mobile medical apps to address the country's opioid crisis.
When President Donald Trump declared a public health emergency over the abuse of heavy-duty painkillers like oxycodone and hydrocodone, he ordered all government agencies to take action in response to the death of 70,000 Americans last year from drug overdoses.
The FDA told Reuters it has received over 200 submissions from companies seeking a speedy approval process for their devices. These range from Stimwave's Halo to painkilling products made by Abbott Laboratories and other industry heavyweights as an alternative to opioids.
"We're pleased by the robust interest in this innovation challenge and the acknowledgement from developers about the unique and important role medical devices, including digital health technologies like mobile medical apps, have the potential to play in tackling the opioid crisis," FDA Commissioner Scott Gottlieb said.
Perryman's Halo devices, which look like angel hair pasta and are so small they can be injected into a nerve, took four years to get U.S. approval under other names for easing leg and back pain.
She hopes a spot on the FDA program will see Halo approved within a year as an alternative to opioids, which are currently used to treat an estimated 50 percent of patients who come to emergency rooms with migraines.
"This is kind of perfect for something like ours...since the device is shown to be safe already," said Perryman, who founded privately-held Stimwave in South Florida seven years ago.
The FDA has been increasingly reluctant to greenlight new opioids for market but earlier this month approved a potent opioid-based painkiller from AcelRx Pharmaceuticals placing tight restrictions on its distribution and use. In a rare move, Gottlieb made a public statement at the time, explaining the decision.
The regulator's push for alternatives to opioids has helped drive interest from venture capital funds and institutional investors this year in firms promising to develop alternatives, according to interviews with device companies, financial services firms and brokerage Cowen & Co.
For example, privately-held Virpax Pharmaceuticals, which makes an aerosol spray that delivers a non-opioid pain drug, said it had four or five banks interested in running its Series A investment round this summer versus just one in the past.