Whatever reason the FDA had in rejecting an application from Daiichi Sankyo and Charleston Laboratories for a new pain drug last February was evidently disturbing enough to persuade the Japanese pharma to abandon any comeback effort — just weeks away from a planned resubmission.
Daiichi Sankyo shrugged off the $200 million it agreed to pay the private biotech three years ago in an upfront and early cash — along with whatever it had paid in the $450 million in milestones it committed to — and handed back all US rights to the drug today.
Their work focused on developing a new pain drug — Jupiter, FL-based Charleston Lab’s leading program for CL-108 — that combined hydrocodone, acetaminophen and promethazine in a way that was designed to avoid nausea and vomiting.
The companies never did explain what prompted the rejection, or how the FDA wanted the collaborators to pull together a resubmission. So we don’t know if regulators dissed the Phase III, wanted another trial, or anything else for that matter.
New FDA Commissioner Scott Gottlieb says that he wants to publish redacted CRLs, but there’s been no recent movement on that front. In the meantime, Charleston Labs says it’s ready to proceed alone.
“We thank Daiichi Sankyo for their partnership, and now with a singular focus, we are excited to rapidly execute our corporate strategy,” said Paul Bosse, the CEO at Charleston Laboratories. “The company will resubmit the CL-108 new drug application (NDA) in the coming weeks, and if approved, CL-108 can help the millions of acute pain patients who require an opioid analgesic while preventing or reducing opioid-induced nausea and vomiting (OINV).
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