FDA Grants Competitive Generic Therapy Designation to Purdue Pharma's Investigational Nalmefene HCl Injection for the Emergency Treatment of Known or Suspected Opioid Overdose
29 April 2019 - - The US Food and Drug Administration 's Office of Generic Drugs has granted Competitive Generic Therapy designation to nalmefene hydrochloride injection, US-based Purdue Pharma L.P.'s investigational opioid antagonist for the emergency treatment of known or suspected opioid overdose, the company said.

This news follows the FDA's recent Fast Track designation for nalmefene HCl, which was announced last month.

The FDA's CGT designation allows for expedited review of generic versions of medications with inadequate generic competition, and is intended to help facilitate the timely market entry of generic drugs.

The Fast Track and CGT designations are timely, as overdose deaths due to opioids continue to rise, driven by abuse of extremely potent and long-lasting synthetic opioid agonists, particularly illicitly manufactured fentanyl and its analogues.

According to the company, 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, the duration of effect of nalmefene HCl injection has the potential to serve as an important alternative for the treatment of opioid overdose.

There is no guarantee that nalmefene HCl injection, an investigational agent, will successfully complete development or gain FDA approval.

Purdue Pharma and its subsidiaries develop and provide prescription medicines. 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, an investment vehicle focused on value-inflection in early stages of clinical development.


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