Charleston Laboratories and partner Daiichi Sankyo have seen the U.S. FDA accept their NDA for CL-108 for the relief of moderate to severe pain while preventing or reducing the associated opioid-induced nausea and vomiting (OINV).
CL-108, a fixed-dose, immediate-release bi-layered tablet, will now be assessed for approval by the U.S.--with a decision currently expected by the end of January next year.
“With this NDA acceptance, patients are one step closer to being able to have an option for relieving pain while also preventing or minimizing the nausea and vomiting side effects of opioid treatment,” said Paul Bosse, president and CEO of Jupiter, FL-based Charleston Laboratories.
“This acceptance represents an important contractual milestone under our relationship with Daiichi Sankyo.”
Mahmoud Ghazzi, MD, PhD, president and global head of development for Daiichi, added: “We look forward to working closely with the FDA during the review process for CL-108 and support the Agency’s efforts to foster the safe and responsible use of opioid medications.”
In 2014, Daiichi said it would pay out as much as $650 million to Charleston Laboratories for its pain meds, with CL-108 its leading candidate.
The drug is a combination of hydrocodone, promethazine and acetaminophen that in 2014 came through in a 465-patient late-stage trial.
The treatment is designed to relieve pain and reduce symptoms of opioid-induced nausea and vomiting. In Phase III, CL-108 met its co-primary endpoints on both measures at high statistical significance.
This is a much-needed win for Daiichi that has endured a tough 12 months. After announcing U.S. layoffs last year as it looks to shore up revenue in the face of a key patent loss, Daiichi was also forced to ditch its lung cancer candidate patritumab earlier this month after it failed to shine in testing.
But the company is seeking a turnaround, and in a corporate update in April, the Japanese pharma said it was looking to spend ¥500 billion ($4.4 billion) on mergers and acquisitions--with a major new focus on buying up cancer drugs. It did hint however that more job cuts may be looming.
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