Shares of AcelRx Pharmaceuticals (NASDAQ:ACRX) are soaring as investors are now predicting that the US Food and Drug Administration advisory committee will approve its opioid painkiller Dsuvia on Friday.
According to briefing papers written by staff reviewers of the FDA, which are out today, AcelRx appears to have made sufficient changes to the drug, which is also known as a sufentanil sublingual tablet, to support its introduction to the market.
“The agency has concluded that the re-submitted [New Drug Application] package supports safe and effective use as intended,” notes Oppenheimer analyst Leland Gershell in a note to investors.
Following a period of discussion, an FDA advisory panel will vote to approve or reject the drug this Friday and US regulators’ final judgement will be made on November 3. US regulators tend to adhere to the recommendations of their panel of experts.
Investors welcomed the news, sending AcelRx shares up 41% to $3.74 in Wednesday’s afternoon session.
To allay US regulators’ concerns about dosing, AcelRx pared back the drug’s maximum daily dose from 24 tablets to 12 and provided new pooled safety analysis. It also modified the drug’s directions and completed a human factors study to address worries that the tablets are easily misplaced due to their small size.
The favorable comments from the FDA come a year after the regulatory agency rejected a new drug application for Dsuvia on the grounds that further safety data and changes to its usage directions were required.
Given that the abuse of opioids has reached crisis levels across the US, the FDA is very cautious about giving the green light to new opioids.
After reading the briefing documents, however, analysts are bullish that Dsuvia will be approved.
“While we expect dropped tablets and their associated risks to be a major topic of discussion and debate, we believe the outcome will be in favor of approval,” wrote Oppenheimer’s Gershell, who is keeping an a Perform rating on the stock, citing his “lukewarm” outlook for Dsuvia’s commercial prospects.
H.C. Wainwright analyst Ed Arce also argues that the “statements and tone of the FDA reviewers are broadly supportive of approval,” according to a research note first published by The Fly, a business news site. Arce is sticking to a Buy rating on AcelRx with a $7 price target.
Cantor Fitzgerald analyst Brandon Folkes, meanwhile, expects a “robust discussion” in Friday’s Advisory committee meeting and thinks a positive vote on Dsuvia being used only in a medically supervised setting is a “real possibility”, according to The Fly.
Lifting his price target on AcelRx to $10 and sticking to a Buy rating on the stock, Ladenburg analyst Michael Higgins said today’s documents “could not be more supportive of Dsuvia”, The Fly said.