FDA approves AcelRx Pharma’s opioid ache drug
(Reuters) – The U.S. Meals and Drug Administration on Friday permitted AcelRx Prescription drugs Inc’s opioid-based therapy for ache for use below strict medical supervision, with the company’s chief highlighting causes for the approval in a uncommon transfer.
FILE PHOTO – A view reveals the U.S. Meals and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed/File Photograph
The regulator’s resolution comes because the U.S. opioid disaster reaches epidemic ranges, claiming lives of an estimated 130 Individuals a day on common, based on the U.S. Facilities for Illness Management and Prevention.
“There are very tight restrictions being placed on the distribution and use of this product,” FDA Commissioner Scott Gottlieb stated in a press release.
Shares of AcelRx jumped 14.9 p.c to $four.77 on Friday.
The fast-acting drug, Dsuvia, will probably be utilized in hospitals, surgical facilities and emergency departments, and its mechanism makes it simpler to ship the place intravenous administration isn’t attainable, the commissioner stated.
The Division of Protection has labored intently with the corporate to develop the drug because it was a precedence product for the Pentagon to fill the unmet want in treating troopers on the battlefield, Gottlieb stated.
The drug is a sublingual tablet type of the widespread injectable opioid sufentanil and is delivered by a pre-filled applicator. The therapy was rejected final 12 months by the company, which had sought extra security knowledge and sure adjustments to make sure that it was administered correctly.
“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 stated.
The corporate says the best way the tablets are delivered ought to forestall unaccounted tablets, a subject of debate forward of the regulator’s resolution.
“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 informed Reuters.
The FDA on Friday individually declined to approve one other opioid-based drug from Trevena Inc, citing insufficient security knowledge.
“Looking beyond this particular drug approval, I believe that we should consider whether we should be doing more to evaluate each candidate opioid,” Gottlieb stated right here
“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 stated.
Reporting by Aakash Jagadeesh Babu and Manas Mishra in Bengaluru; Modifying by Sriraj Kalluvila and Anil D’Silva