By Manas Mishra and Aakash B
(Reuters) – The U.S. Food and Drug Administration on Friday approved AcelRx Pharmaceuticals Inc’s opioid-based treatment for pain to be used under strict medical supervision, with the agency’s chief highlighting reasons for the approval in a rare move.
The regulator’s decision comes as the U.S. opioid crisis reaches epidemic levels, claiming lives of an estimated 130 Americans a day on average, according to the U.S. Centers for Disease Control and Prevention.
“There are very tight restrictions being placed on the distribution and use of this product,” FDA Commissioner Scott Gottlieb said in a statement.
Shares of AcelRx jumped 14.9 percent to $4.77 on Friday.
The fast-acting drug, Dsuvia, will be used in hospitals, surgical centers and emergency departments, and its mechanism makes it easier to deliver where intravenous administration is not possible, the commissioner said.
The Department of Defense has worked closely with the company to develop the drug as it was a priority product for the Pentagon to fill the unmet need in treating soldiers on the battlefield, Gottlieb said.
The drug is a sublingual pill form of the common injectable opioid sufentanil and is delivered through a pre-filled applicator. The treatment was rejected last year by the agency, which had sought additional safety data and certain changes to ensure that it was administered properly. “This approval comes amidst robust public debate on whether additional opioids should be approved that was addressed by FDA Commissioner Scott Gottlieb in an unusual public statement today which we think speaks to marketplace need for the product,” RBC Capital Markets analyst Randall Stanicky said.
The company says the way the tablets are delivered should prevent unaccounted pills, a topic of discussion ahead of the regulator’s decision.
“We believe that the single dose that is going directly through the nurse to a patient’s mouth is a more fool-proof way of delivery,” AcelRx Chief Medical Officer Pamela Palmer told Reuters.
The FDA on Friday separately declined to approve another opioid-based drug from Trevena Inc, citing inadequate safety data.
“Looking beyond this particular drug approval, I believe that we should consider whether we should be doing more to evaluate each candidate opioid,” Gottlieb said https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm624968.htm.
“We should consider whether we could do more in weighing approvals to ensure that new opioids are sufficiently better than existing drugs to justify their addition to the market in the context of the current crisis of abuse,” he said.
(Reporting by Aakash Jagadeesh Babu and Manas Mishra in Bengaluru; Editing by Sriraj Kalluvila and Anil D’Silva)