Lightlake Therapeutics has collaborated with the Division of Pharmacotherapies and Medical Consequences of Drug Abuse (DPMCDA), part of the US the National Institute on Drug Abuse (NIDA), to co-develop a treatment for opioid addiction.
The collaboration aims to establish a clinical development plan and regulatory pathway leading to FDA approval and commercialisation of a new pharmaceutical treatment that addresses the complications of opioid addiction within 18 months.
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Lightlake chief executive officer Dr Roger Crystal said; "This is a growing US health concern, and a complex issue to address, because there are multiple opioid-based drugs being used, both illegally and prescribed.
"Lightlake is leveraging its substantial expertise in opioid antagonists to develop a pharmaceutical solution that is efficient, pragmatic, and cost-effective."
According to the deal, DPMCDA will sponsor a Phase I study in which 14 healthy volunteer subjects will participate to assess the pharmacokinetic properties of Lightlake’s product candidate.
If the study is successful, IDA anticipates filing an IND for a larger, final study.
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By GlobalDataImage: National Institutes of Health Clinical Center, located in Bethesda, Maryland US. Photo: Courtesy of Christopher Ziemnowicz.
