Shares of AcelRx Pharmaceuticals Inc. jumped Oct. 10 as a U.S. Food and Drug Administration committee said the company's opioid drug Dsuvia was safe and effective based on resubmitted data.
The FDA's Anesthetic and Analgesic Drug Products Advisory Committee is hosting a meeting Oct. 12 to review AcelRX's application for Dsuvia, an opioid painkiller that was designed to eliminate dosing errors through a non-invasive single-dose applicator. Also known as sufentanil sublingual tablet, Dsuvia manages moderate to severe acute pain in medically supervised settings in adult patients.
AcelRX resubmitted a new drug application for drug-device combination Dsuvia in May after addressing concerns raised by the FDA in its rejection of the first application for the pain treatment. The FDA rejected the drug based on concerns about the maximum dosage and the risk of misplaced tablets. In response, AcelRX reduced the daily maximum dose from 24 tablets to 12, and to prevent misplaced pills, modified the directions for use and performed another human factors validation study.
Ahead of the formal meeting to review the resubmitted application, the committee released briefing materials that show the committee intends to recommend that Dsuvia is safe and effective. The committee will vote on the recommendation at the meeting, which will then be passed on to the FDA. The FDA will then issue a final determination on Dsuvia by Nov. 3.
The committee said the treatment of acute pain must be balanced with protecting public health amid the opioid addiction crisis in the U.S. But the benefits of Dsuvia "may outweigh the risk of accidental exposure" if the drug is administered by a healthcare professional only in certified medically supervised settings, the committee said in its briefing materials. Dsuvia is not intended for outpatient use.
"If restricted to medically supervised settings in which sufentanil sublingual tablet 30 mcg was studied, such as hospitals, emergency departments, and surgery centers, it would reduce the risk of accidental exposure," the committee said.
The Redwood City, Calif.-based company's shares rose by nearly 40% to $3.70 as of 4 p.m. ET on Oct. 10, according to data from S&P Global Market Intelligence.
Dsuvia, marketed in Europe under the name Dzuveo, was approved by the European Commission in June.