Teva Pharmaceuticals Receives FDA Approval for First Generic Naloxone Nasal Spray to Treat Opioid Overdose

VCBeat (WeChat ID: vcbeat) has learned that the generic naloxone nasal spray developed by biopharmaceutical company Teva Pharmaceuticals has recently received approval from the U.S. Food and Drug Administration (FDA) for market launch, to be used in the treatment of opioid overdose. This is the first FDA-approved generic version of naloxone.

In cases of opioid overdose, patients may experience shallow breathing or complete respiratory arrest, which can be fatal if not treated promptly. Rapid administration of naloxone nasal spray can restore normal breathing within minutes. Each package contains two nasal sprays and is priced at approximately $130 to $150. Teva Pharmaceuticals has not yet announced the specific launch date for this product in the United States.

This medication is a generic version of Narcan. Developed by Adapt Pharma, a pharmaceutical company based in Pennsylvania, USA, Narcan was the first naloxone hydrochloride nasal spray approved by the FDA. It can block or reverse the effects of opioid overdose and received approval on November 8, 2015. Narcan can be used in adults and children and is easy for anyone to administer; treatment is completed simply by spraying the medication into the nose.

Teva Pharmaceutical Industries Ltd., founded in 1901 and headquartered in Jerusalem, Israel, is a generic pharmaceutical manufacturer and one of the global leaders in the healthcare sector. The company focuses on developing affordable, high-quality generic medicines for patients with central nervous system and respiratory diseases, enabling people to live better and healthier lives.

Teva Pharmaceuticals is one of the top three generic drug companies globally, with a portfolio of over 1,800 medications, more than 80 production facilities, and an annual output exceeding 88 billion tablets and capsules. The company’s products are sold in over 60 countries and regions worldwide, and it employs approximately 45,000 people.

Dr. Douglas Throckmorton, Deputy Director for Regulatory Programs at the FDA’s Center for Drug Evaluation and Research (CDER), stated, “The opioid crisis is sweeping across the United States, and the FDA is working to make overdose-reversal medications more accessible to patients experiencing opioid overdoses. We have approved the first generic version of naloxone nasal spray, and we will prioritize the review of subsequent generic drug applications for naloxone products. Additionally, the FDA is considering co-packaging naloxone with some or all opioid medications as a standard practice to mitigate the risk of overdose.”

Opioids primarily include morphine, codeine, compound camphor tincture, and papaverine. Long-term use of opioids can lead to addiction. In the United States, the opioid abuse crisis has persisted for 20 years. According to data from the U.S. Centers for Disease Control and Prevention (CDC), nearly 400,000 people in the United States died from opioid overdoses between 1999 and 2017. In the United States, the number of deaths caused by opioid overdoses has far exceeded the number of deaths from car accidents.

(Compiled by Jiao Yanli)