AcelRx Shares React Positively To FDA Committee Briefing On Painkiller Candidate Dsuvia

A day after Trevena Inc TRVN shares suffered a setback in reaction to a FDA committe's briefing document, another stock is trading higher following the release of a briefing document pertaining to its adcom review.

What Happened

The briefing document released by FDA's Anesthetic and Analgesic Drug Products Advisory Committee, which is evaluating AcelRx Pharmaceuticals Inc ACRX's new drug application for Dsuvia, said the dose and dosage regimen appear effective in the drug's proposed population and reasonably safe in the context of existing opioid therapy.

The 30-mcg of sufentanil sublingual tablets are intended to treat moderate-to-severe acute pain that requires an opioid analgesic and for which alternative treatments are inadequate.

The committee's suggested discussion points for an adcom meeting set for Friday include concerns over misplaced tablets due to the drug's potential for abuse, misuse and accidental exposure and Dsuvia's benefit-risk profile. 

Why It's Important

Dsuvia is AcelRx's lead product candidate. Dsuvia is known as Dzuveo outside of the U.S. and received European Union approval in late June. 

What's Next

AcelRx resubmitted the NDA for Dsuvia following the issuance of a complete response letter in October 2017 due to concerns regarding safety at the highest dose mentioned in the labeling and the risk of misplaced tablets.

The FDA accepted the resubmitted application May 24. The PDUFA date is set for Nov. 3.

To address the concerns, the company reduced the maximum daily dose from 24 tablets to 12 tablets and submitted a pooled safety analysis, performed a new human factors study and submitted a risk assessment for accidental exposure to the medication.

If approved, Dsuvia would be administered by health care professionals in settings such as hospitals, emergency rooms and surgical centers. 

Ahead of the PDUFA, the adcom meeting announcement scheduled for Friday is a key catalyst for the stock.

Ladenburg Thalmann reiterated its Buy rating on AcelRX and raised its price target from $7 to $10 Wenesday. 

AcelRx shares, which were down about 50 percent at one point in pre-market trading Wednesday, have reacted positively to the recommendations in the briefing document.

The stock was up 33.21 percent at $3.53 at the time of publication Wednesday on roughly 17 times its average volume.

Editor's note: This story has been updated to make a clearer distinction between the latest FDA committee briefing document on Dsuvia and the agency's initial review of the drug. 

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