10 June 2019 - - The first patient has been dosed in a Phase 1 clinical study that will examine pharmacokinetic properties of nalmefene hydrochloride, US-based Purdue Pharma L.P.'s said.
This milestone comes at a time when deaths resulting from synthetic opioid overdose are at record highs, and follows the US Food and Drug Administration 's recent Competitive Generic Therapy and Fast Track designations for Purdue's nalmefene HCl injection for the emergency treatment of known or suspected opioid overdose, which were announced earlier this year.
The NAL1002 study is part of Purdue's development program and plan to make nalmefene HCl injection available as quickly as possible to the patients who need it most.
As part of the programme, Purdue is developing nalmefene HCl injection as a generic product in vial and pre-filled syringe formats, and as an autoinjector through the 505(b) (2) pathway.
The first participant has now been enrolled and dosed in NAL1002, a Phase 1 study evaluating the pharmacokinetic and pharmacodynamic responses to various formulations of nalmefene HCl.
The first part of this study will compare pharmacokinetic profiles from healthy adult male and female subjects following administration of nalmefene HCl intramuscularly and intravenously at various doses. Initial results from the study are expected in Q3.
Nalmefene HCl has a longer duration of action than naloxone, another opioid antagonist currently approved for emergency treatment of known or suspected opioid overdose.
If approved, nalmefene HCl injection has the potential to serve as an important alternative for the treatment of opioid overdose.
Purdue established Imbrium Therapeutics L.P. to further advance its emerging portfolio and develop its pipeline in the areas of CNS, non-opioid pain medicines, and select oncology through internal research, strategic collaborations and partnerships.
Purdue's subsidiaries also include Adlon Therapeutics L.P., focused on treatment for Attention-Deficit/Hyperactivity Disorder and related disorders, and Greenfield Bioventures L.P., an investment vehicle focused on value-inflection in early stages of clinical development.