Shares of AcelRx Inc (NASDAQ:ACRX) are on the rise following the controversial approval by the US Food and Drug Administration of its opioid pain treatment drug Dsuvia.
In a rare move, US regulators have given the green light for the opioid Dsuvia to be used under strict medical supervision at a time when the US opioid crisis has escalated and health officials are looking to crack down on the addictive drugs.
In response, investors sent AcelRx shares up 3% before the opening bell on Monday to $4.95.
Taken by mouth, the quick-acting Dsuvia, which is a form of the opioid sufentanil, will be be used in hospitals as well as surgical centers and emergency departments as an alternative to injectable opioids.
The drug was a priority medical product for the Pentagon which is intending to use it to treat soldiers on the battlefield.
But the drug's approval has generated considerable controversy as it is far more potent than both morphine and fentanyl.
“An opioid that is a thousand times more powerful than morphine is a thousand times more likely to be abused, and a thousand times more likely to kill,” said Senator Edward Markey, a Democrat from Massachussetts in a statement last month.
Leland Gershell, an analyst with Oppenheimer, is also remaining on the sidelines about AcelRx's new drug approval, despite the US military having the option to buy 112,000 units of Dsuvia.
"We are on the sidelines as we expect lackluster revenues for both Dsuvia and Zalviso relative to the large acute pain market," he wrote in a note to investors.
Like all opioids, Dsuvia will carry a warning about the risks of misuse and abuse, which can lead to addiction, overdose and death.
READ: AcelRx Pharmaceuticals shares soar following FDA advisory committee’s approval vote for Dsuvia
To address concerns about its potential risks, Dsuvia won’t be available in retail pharmacies or for home use. It should also not be used for more than 72 consecutive hours, said FDA Commissioner Scott Gottlieb in a statement.
“Dsuvia, which was previously approved by the European Medicines Agency in July under the brand name Dzuveo, has some unique features in that the drug is delivered in a stable form that makes it ideally suited for certain special circumstances where patients may not be able to swallow oral medication, and where access to intravenous pain relief is not possible,” Gottlieb said.
The drug was rejected by the FDA last year due to concerns about its dosing and usage directions.
Since then, AcelRx has lowered the drug’s maximum daily dose from 24 tablets to 12 tablets and provided new safety analysis.
The drug’s directions were updated and a study was conducted to address concerns that the small size of the tablets would make them easy to misplace.
Last month, the Anesthetic and Analgesic Drug Products Advisory Committee of the FDA voted 10-3 in favor of approving Dsuvia for managing moderate-to-severe acute pain in medically supervised settings for adults.
Dsuvia’s commercial launch is expected in the first quarter of next year.
Contact Ellen Kelleher at [email protected]