Japan's Daiichi Sankyo has made developing a portfolio of pain-management products a key R&D focus and just added two new drugs to the mix.
The company has licensed U.S. rights to Inspirion Delivery Sciences' already-approved MorphaBond (morphine sulfate)--an abuse-deterrent version of the opioid analgesic drug--as well as a follow-up in development.
MorphaBond's formulation is designed to resist being broken up and dissolved in a liquid, a standard tactic used by drug abusers who want to inject prescription painkillers, says a Daiichi Sankyo statement. The formulation forms a viscous material when dissolved that resists passage through a syringe needle.
The development of improved abuse-deterrent painkillers is a priority for the FDA in light of an epidemic in overdoses and deaths from opioid drugs, driven by an estimated 4.3 million people in the U.S. who regularly use these drugs for nonmedical purposes. According to federal data, there were nearly 19,000 deaths involving prescription opioids in the U.S. in 2014, a 16% increase on the prior year.
It's not necessarily easy to persuade the FDA to label a new opioid as abuse-deterrent, however. Just ask Endo and KemPharm, which both had applications for their candidates slapped down earlier this year after failing to meet the regulator's stringent criteria.
Perhaps stung by criticisms that it has allowed abuse-resistant claims in the past for drugs that according to critics are in fact quite easily abused--witness the furor that followed the approval of Zogenix's Zohydro ER last year--the regulatory agency has tightened up its criteria for a deterrent claim, publishing new guidance on the topic last year.
Daiichi Sankyo entered the U.S. pain-management sector last year when it signed up to help AstraZeneca market Movantik (naloxegol), used to treat constipation caused by prolonged opioid analgesic use. MorphaBond gives Daiichi Sankyo another commercial product while it brings forward its existing pain management pipeline, currently headed by mirogabalin and CL-108 in Phase III testing.
Mirogabalin is in development for the treatment of fibromyalgia and pain caused by nerve damage resulting from diabetes or herpesvirus infection, and is billed as a superior and safer competitor to Pfizer's ($PFE) blockbuster Lyrica (pregabalin), which made $2.7 billion last year.
CL-108 combines an opioid painkiller with a drug that inhibits the nausea and vomiting seen in around 40% of patients who take opioids. Daiichi Sankyo licensed that drug from Charleston Laboratories for $100 million upfront plus another $100 million tied to an undisclosed near-term milestone.
The Japanese drugmaker reckons that the overall pain market was worth around $28 billion in the U.S. last year and said in its latest five-year strategic plan that it is hoping to build its own sales to almost $1 billion by 2020.
Editor's note: This story was updated to correct information about the 40% patients who experience OINV when receiving opioids. The number is not just for patients receiving opioids for chronic pain but also includes those for acute use.
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