Charleston Laboratories and Daiichi Sankyo’s NDA for CL-108 receives FDA acceptance

14 June 2016 (Last Updated June 14th, 2016 18:30)

The collaboration of US-based pharmaceutical company Charleston Laboratories and Japanese pharmaceutical company Daiichi Sankyo has received acceptance from the US Food and Drug Administration (FDA) for reviewing the New Drug Application (NDA) for CL-108.

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The collaboration of US-based pharmaceutical company Charleston Laboratories and Japanese pharmaceutical company Daiichi Sankyo has received acceptance from the US Food and Drug Administration (FDA) for reviewing the New Drug Application (NDA) for CL-108.

CL-108 is a fixed-dose, immediate-release, bi-layered tablet that can be used to relieve moderate to severe pain while preventing or reducing the associated opioid-induced nausea and vomiting (OINV).

Opioids, substances that work on opioid receptors to create morphine-like effects, include opiates, which is an older term referring to drugs that are derived from opium, including morphine itself.

The two layers of the tablet comprises a rapid release layer containing 12.5mg of promethazine, and a second layer containing 7.5mg of hydrocodone and 325mg of acetaminophen.

"At Charleston Laboratories, a key part of our mission is to develop and commercialise products that provide patients with novel solutions for improving their pain management."

Charleston Laboratories president and CEO Paul Bosse said: "With this NDA acceptance, patients are one step closer to being able to have an option for relieving pain while also preventing or minimising the nausea and vomiting side effects of opioid treatment.

"At Charleston Laboratories, a key part of our mission is to develop and commercialise products that provide patients with novel solutions for improving their pain management."

The NDA for CL-108 is supported by two major randomised, double-blind, placebo-controlled and active-controlled Phase III clinical studies.

The first study involves an oral surgery (molar removal), while the second involves post bunionectomy surgery (removal of bunions from the foot), as well as by an additional Phase III open-label, actual use safety study in patients with moderate-to-severe acute pain or flares that are associated with osteoarthritis of the knee or hip.


Image: A sample of raw opium. Photo: courtesy of Erik Fenderson.