Purdue inks Shionogi collab on constipation med as it awaits FDA approval

The FDA is set to make a decision on the med by the end of March next year.

Purdue has signed a new deal with Japanese drugmaker Shionogi that will see the pair work together to sell in the U.S. the latter’s opioid-induced constipation (OIC) candidate Symproic (naldemedine).

The drug, currently under review by the FDA, is set for a decision on March 23 next year in OIC patients with chronic noncancer pain.

Should it be approved, Symproic, a peripherally acting mu opioid receptor antagonist (PAMORA), will see Purdue combine its know-how in the pain marketing space with Shionogi’s knowledge as the inventor and global developer of naldemedine.

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Purdue said in a statement that, together with Shionogi, the two are set to jointly launch and commercialize Symproic, including a comprehensive collaboration on all aspects of strategy, sales, and other activities.

This comes after a tough 2015 for Purdue, as in September it saw a panel of FDA advisers voting against approving the latest pain treatment from the company as it worried that quirks in the pill's dosing could put patients at risk.

The agency's independent analgesics committee voted 23-1 against recommending Purdue's Avridi, a formulation of the opioid oxycodone designed to be harder to abuse than painkillers past.

Panelists worried about the drug's relationship with food: Avridi, an immediate-release painkiller, is meant to be taken every four to 6 hours on an empty stomach for maximum efficacy.

There has been better luck for its new partner as, back in February, Shionogi said its in-development treatment for OIC met its main goal in a late-stage trial, a positive development for the company as it moves toward a fast-crowding market.

Symproic met its primary endpoint by increasing the frequency of bowel movements for 47.9% of patients in at least 9 of the study's 12 weeks, Shionogi said. That marked a statistically significant improvement over placebo, which made a 34.6% difference.

The latest results, presented at the American Academy of Pain Medicine at the start of the year, marked the third phase 3 success for the med and saw the company file for FDA approval a few months later.

This comes after AstraZeneca recently launched its OIC treatment Movantik (naloxegol), which competes with Sucampo Pharmaceuticals’ Amitiza (lubiprostone) and Valeant’s Relistor (methylnaltrexone bromide) in the space. 

After its FDA hit last year, Purdue announced plans to spin out some of its in-development pain drugs in a joint venture with AnaBios, tapping the biotech's development tech to speed along a handful of early-stage projects. Earlier this month, Purdue said it would also license to AnaBios the rights to a suite of patents for Nav1.7 sodium ion channel blockers. The two companies have now formed a joint steering committee to manage preclinical as well as clinical development of the lead molecule.

The privately held drugmaker also signed a deal last year worth as much as $213 million to bring another potential painkiller to market. Under an agreement with VM Pharma, Purdue licensed an antagonist of the signaling protein TrkA, which regulates nerve growth and plays a role in chronic pain. 

And Purdue has been reaching outside of its home market in chronic pain to expand its pipeline, last year signing a deal with another Japanese drugmaker, this time Eisai, to split the costs of lemborexant, a phase 3 insomnia treatment the company believes could become a disruptive force on the market for sleep aids.

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