Durect’s perseverance with its non-opioid painkiller, Posimir, looks puzzling, especially with the group recently cutting development costs for its new hope, DUR-928. The company plans to reply to a 2014 US FDA complete response letter for Posimir, despite the failure of a subsequent phase III trial, Persist. Pressing on looks like throwing good money after bad, especially as Durect is not exactly rolling in cash: it had $41.5m in cash and $20m debt at the end of September. In January the group cut back its DUR-928 programme, winding down efforts in primary sclerosing cholangitis and alcoholic hepatitis to focus on psoriasis and Nash; a phase I trial in the latter is due to start dosing this quarter. In lodging a response to Posimir’s CRL the company might have a chance of approval, however slim, without shelling out for another trial. And if approved, Durect could seek another partner for Posimir, Stifel analysts noted. Posimir, an extended-release formulation of bupivacaine, had previously been partnered with Novartis’s Sandoz division, but that group recently returned rights to Durect. Still, getting the go-ahead for Posimir looks like a long shot, so Durect might soon be looking for another source of funds.
|Development of Durect’s DUR-928|
|Psoriasis (topical)||Phase IIa||NCT03837743||H2 2019|
|Alcoholic hepatitis (IV)||Phase IIa||NCT03432260*||Primary completion Mar 2019|
|Nash (oral)||Phase I to begin Q1 2019||-||H2 2019|
|Primary sclerosing cholangitis (oral)||Phase II discontinued||NCT03394781||N/A|
|*Tranferring to University of Louisville. Source: Clinicaltrials.gov.|