Brand Institute Partners on Brand Name Development for FDA-Approved Nasal Spray to Reverse Fentanyl and Other Opioid Overdoses
30 May 2023
Drug Approval
MIAMI, May 30, 2023 /PRNewswire/ -- Brand Institute is proud to announce its work in developing the brand name Opvee™ (nalmefene) Nasal Spray from Indivior (through its wholly owned subsidiary, Opiant Pharmaceuticals, Inc.), which was approved by the U.S. Food and Drug Administration (FDA) on May 22, 2023.
Opvee is indicated for the emergency treatment of known or suspected overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older, as manifested by respiratory and/or central nervous system depression. Opvee is the first FDA-approved nasal spray formulation of nalmefene.
In a recent press release, FDA Commissioner Robert M. Califf, M.D. stated, "The availability of nalmefene nasal spray places a new prescription opioid reversal option in the hands of communities, harm reduction groups and emergency responders."
"The entire Brand Institute and Drug Safety Institute team congratulates Indivior on the FDA approval of Opvee," said Brand Institute's Chairman and C.E.O., James L. Dettore. "The rising overdose rates in the US is alarming and we hope Opvee's innovative nasal spray format helps fight this growing addiction crisis."
About Brand Institute and its wholly owned subsidiary, Drug Safety Institute
Brand Institute has a portfolio of over 5,000 marketed healthcare and consumer brands for more than 1,600 clients. The company partners on over 75% of pharmaceutical brand and nonproprietary name approvals globally every year. Drug Safety Institute is composed of former naming regulatory officials from global government health agencies, including the FDA, European Medicines Agency (EMA), Health Canada, American Medical Association (AMA), and the WHO. These regulatory experts co-authored the name review guidelines with their respective agencies, with many responsible for ultimately approving (or rejecting) brand name applications. Now working for a private company, these professionals provide Brand Institute's clients with industry-leading guidance pertaining to drug name safety (i.e., preventing medication errors), packaging, and labeling.
Contact:
[email protected]
www.brandinstitute.com
SOURCE Brand Institute, Inc.
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