Durect's non-opioid painkiller brushes aside checkered past, gaining FDA approval in shoulder surgeries
After a long and often bumpy ride, Durect’s non-opioid painkiller has received the FDA’s endorsement.
US regulators approved the sustained-release bupivacaine solution for use up to 72 hours after certain shoulder surgeries, Durect announced Tuesday morning. The drug is called Posimir, and its approval breathes life into a company that once teetered on penny stock territory after the program racked up two trial failures and a CRL.
Durect’s $DRRX shares shot up about 24% in early Tuesday trading. The company will be required to conduct two postmarketing, non-clinical studies.
Doctors will be able to use the drug in what’s called subacromial decompression surgeries that treat shoulder impingements. The injuries stem from too much repetitive use and cause pain when individuals raise their arms over their heads.
Normally, such surgeries are performed arthroscopically in an outpatient setting, inserting surgical instruments into small incisions made in the shoulder with the aid of a small camera. The idea behind the drug is to deliver it directly into the shoulder space between the collarbone and ball-and-socket joint once the surgery itself is completed.
Posimir then functions as a local analgesic and an alternative to oral opioid painkillers typically administered in recovery. The first three days after the surgery are usually the most painful, Durect says, and Posimir continuously releases bupivacaine in the shoulder for 72 hours or more to combat that pain.
The company added that the 660 mg of bupivacaine contained in the drug is more than any other approved single-dose, sustained-release bupivacaine product. Durect is aiming at a market that sees about 600,000 such shoulder surgeries per year where full recovery time can last from weeks to months.
For now, Posimir will be limited to this type of procedure, as the drug is not indicated for soft tissue surgical procedures or other orthopedic procedures, such as administration into a joint or bone.
Posimir’s rocky history began several years ago. Durect reported a trial failure back in 2012, and in 2014 the FDA rejected its pitch over safety concerns. After regulators requested a change to the trial in 2016, Durect conducted another study divided into two parts: a placebo arm and comparator arm.
That study also flopped in 2017, demonstrating no statistical difference in patient response between the arms in pain reduction for the first 48 hours after surgery. The news sent Durect shares crashing into penny stock territory at the time and also dinged its partner Novartis, where the Sandoz unit had paid $20 million upfront in a $293 million deal.
Posimir returned to the FDA in an adcomm in January 2020, and the panel could not decide whether to recommend approval. It split down the middle with a 6-6 vote, noting neurological safety concerns and suggesting the therapy’s duration of action was limited to 12 to 24 hours. Those in favor of approval noted patients could see benefits simply because the drug is not an opioid.