DUR-928 Developer Durect Joins with Sandoz on Posimir Pain Reliever System Efforts

DUR-928 Developer Durect Joins with Sandoz on Posimir Pain Reliever System Efforts

Durect has signed an agreement with Sandoz to develop and market Posimir (Saber-bupivacaine), an investigational localized pain reliever, in the United States.

Durect is working on several product candidates, including DUR-928 for the treatment of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH), among others.

DUR-928 is an endogenous orally bioavailable small molecule that is showing promising results in modulating the activity of nuclear receptors, playing an important regulatory role in lipid levels, inflammation and cell survival.

Pharmacokinetics studies in animal models have shown DUR-928 to be nontoxic at plasma concentrations up to several thousand times naturally occurring levels. Durect is examining the potential application of DUR-928 to human chronic metabolic diseases, such as NAFLD, NASH and non-metabolic liver disorders, among others.

DUR-928 has shown potential in reducing liver lipid accumulation without inducing hyperlipidemia (high lipid levels in the blood), reducing liver fibrosis and inflammation.

It is being investigated in a single-ascending-dose Phase 1b trial in patients with NASH, according to Durect.

Like DUR-928, Posimir is an investigational candidate. It is being tested as a non-opioid analgesic intended to provide pain relief after gall bladder removal surgery.

Posimir is a locally acting, extended-release therapy that uses Durect’s patented Saber technology. It is designed to continuously deliver bupivacaine to the surgical site for 72 hours, providing up to three days of continuous pain relief after surgery.

The therapy is being evaluated in a Phase 3 PERSIST clinical trial (NCT02574520) in patients undergoing laparoscopic cholecystectomy (gall bladder removal). The trial is comparing the effects of Posimir to those of bupivacaine HCI. This trial is currently recruiting participants.

Under the terms of the agreement, Sandoz will give Durect $20 million upfront, with the potential for up to $43 million more in development and regulatory milestones and up to an additional $230 million in sales-based milestones, among others.

“We are delighted to collaborate with a company with the market presence and resources of Sandoz to commercialize Posimir in the United States,” James E. Brown, president and CEO of Durect, said in a press release. “We believe that Posimir has the potential to become a cornerstone of multi-modal post-operative pain management. As a non-opioid local analgesic, we believe Posimir may be an important contributor to the ongoing efforts to reduce the use of opioid-based medications following surgery.”

Neither DUR-928 nor Posimir have been approved yet by the U.S. Food and Drug Administration or any other health authorities for marketing.

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