An FDA advisory committee gave the nod to AcelRX’s potent opioid drug Dsuvia on Friday, recommending it should be approved in the US to treat moderate-to-severe acute pain, but under the supervision of medical professionals only.
This is good news for the company, which saw the FDA reject its new drug application last year. This time the application included a Risk Evaluation Mitigation Strategy (REMS), stating that the drug must be administered by a trained healthcare professional to avoid substance abuse and accidental exposures. This measure has helped to swing the committee in favour of the drug.
Opioid abuse has reached epidemic proportions in the US, and the FDA has played its part in refusing approval to treatments that could be abused, while promoting treatments which are abuse-resistant.
The drug is a new formulation of sufentanil, which is currently administered intravenously in hospital settings. Unlike intravenous-based opioids, Dsuvia, which is already approved in the EU, could allow for a more effective and less invasive pain reliever.
Delivered via a pre-filled, single-dose applicator, the sufentanil-derived drug is up to 10 times more potent than its parent drug fentanyl and 500 times more potent as morphine according to the company.
If given the final OK, the company notes that the drug would be the first new opioid treatment approved this year by the FDA.
Evaluating the safety and effectiveness of products for use in anaesthesiology and surgery, the Anaesthetic and Analgesic Drug Products Advisory Committee voted 10 to 3 in favour of the drug.
While the US regulator is under no obligation to go ahead with the panel’s ruling, it does tend to follow suit, so an approval is looking likely.
“We are pleased with the Advisory Committee’s recommendation to approve Dsuvia as a treatment in medically supervised settings for adults experiencing moderate-to-severe acute pain,” said Dr. Pamela Palmer, Co-Founder and Chief Medical Officer of AcelRx.
If approved, AcelRx could potentially tap into a market worth an estimated $1.1bn, and due to Dsuvia’s ease of administration, the pharma company could be on course to doing just that.
“We look forward to continued collaboration with the FDA on the application as we believe Dsuvia represents an important non-invasive acute pain management option with potential to significantly improve the current standard of care.”
Also in the application was efficacy and safety data from two randomised, placebo-controlled studies, which showed Dsuvia to be well-tolerated and efficacious across a range of patient ages and BMIs.
Meanwhile, Trevena’s intravenous opioid olicerdine for the management of moderate-to-severe acute pain in adult patients narrowly missed out on a recommendation from the committee, with eight members voting against the drug to seven in favour.
The FDA is set to make its decision by 2 November, but the lack of confidence from the committee, and along with the company’s shareholders, makes an approval a lot less likely.