When President 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 opioid 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.
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 Inc 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.
Abbott, like rivals Boston Scientific Corp and Nevro Corp, makes neuromodulation implants which stimulate the nervous system to mask pain signals before they reach the brain.
Abbott has submitted an entry for the competition in the hope it will slash waiting times, which often stretch several months just to get an initial meeting, according to Dr. Allen Burton, Abbott’s medical director of neuromodulation.
While neuromodulation is only a small part of Abbott’s large medical device business, the unit is seen as a growth engine for the company. Burton estimates between 10-to-20 percent of the growth Abbott has seen in its neuromodulation business could be tied to doctors prescribing its devices for pain after surgery or from injury to patients that are opioid averse.
Boston Scientific did not apply for the contest, but the company is investing “heavily” in its neuromodulation unit, which was its fastest-growing at nearly 23 percent in the latest quarter.
Although the FDA contest is limited to devices and app-based solutions for pain and addiction, the current regulatory climate is also conducive to companies developing opioid-alternative pharmaceuticals.
Drugmakers including Pfizer Inc, Eli Lilly and Co, Regeneron Pharmaceuticals Inc and Teva Pharmaceutical Industries Inc have been packing their pipelines with potential solutions to the crisis and there are 120 non-opioid drugs under FDA review this year, up some 650 percent since 2013, according to business intelligence firm Informa.