FDA accepts for review Adapt Pharma’s NARCAN® (naloxone hydrochloride) Nasal Spray NDA
September 24, 2015
FDA Grants Priority Review Status
Dublin, Ireland, September 24, 2015 – Adapt Pharma Limited (Adapt Pharma) announced today that the U.S. Food and Drug Administration (FDA) accepted for filing its New Drug Application (NDA) for NARCAN® (naloxone hydrochloride) Nasal Spray and granted Priority Review. NARCAN® Nasal Spray had previously been granted Fast Track Designation by the FDA, and Adapt Pharma submitted an NDA in July 2015.
NARCAN® Nasal Spray is an investigational drug designed to provide a dose of naloxone in a nasal spray formulation. It is intended as an emergency treatment for known or suspected opioid overdose. Naloxone has been used as the standard treatment for opioid overdose for almost 45 years, but currently is only FDA approved in injectable formulations. NARCAN® Nasal Spray was developed in collaboration with the National Institutes on Drug Abuse (NIDA). (See “About Naloxone” below for important safety information).
“NARCAN® Nasal Spray was designed as a ready-to-use option to facilitate the administration of naloxone wherever an opioidoverdose emergency happens,” said Seamus Mulligan, chairman and CEO of Adapt Pharma.
Use of prescription opioids for the long-term management of chronic pain, or abuse of drugs such as heroin, may involve the potential risk of a life-threatening opioid overdose where breathing and heartbeat slow or stop.[iii] Opioids include morphine, codeine, methadone, oxycodone (e.g., OxyContin®, Percocet®), hydrocodone (e.g., Vicodin®, Lortab®), fentanyl (e.g., Duragesic®, Fentora®), hydromorphone (e.g., Dilaudid®, Exalgo®), and buprenorphine (Subutex®, Suboxone®). [iii]
Naloxone administration is not a substitute for emergency medical care.
Due to the duration of action, the patient must be kept under continued surveillance and repeated doses of naloxone should be administered, as necessary, while awaiting emergency medical assistance. Other supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance. Reversal of respiratory depression by partial agonists or mixed agonists/antagonists such as buprenorphine and pentazocine may be incomplete. Use in patients who are opioid dependent may precipitate acute abstinence syndrome. Patients with pre-existing cardiac disease or patients who have received medications with potential adverse cardiovascular effects should be monitored in an appropriate healthcare setting. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated.
The following adverse reactions have been identified during use of naloxone hydrochloride in the post-operative setting: hypotension, hypertension, ventricular tachycardia and fibrillation, dyspnea, pulmonary edema, and cardiac arrest. Death, coma and encephalopathy have been reported as sequelae of these events. Excessive doses of naloxone hydrochloride in post-operative patients have resulted in significant reversal of analgesia and have caused agitation. Abrupt reversal of opioid effects in persons who were physically dependent on opioids has precipitated signs and symptoms of opioid withdrawal including: body aches, fever, sweating, runny nose, sneezing, piloerection, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, abdominal cramps, increased blood pressure and tachycardia. In the neonate, opioid withdrawal signs and symptoms also included: convulsions, excessive crying and hyperactive reflexes.
About Priority Review
Priority Review is granted by the FDA to medications that, if approved, would be significant improvements in the safety or effectiveness of treatment, compared to the standard therapy. Priority Review accelerates the FDA target action date to six months from the NDA acceptance date.[iv]
About Adapt Pharma
Adapt Pharma is a privately-held pharmaceutical company committed to positively impacting the lives of patients. Adapt Pharma’s strategy is to identify, evaluate, selectively acquire and enhance the value of late stage development and FDA-approved pharmaceutical products. Adapt Pharma’s company headquarters are in Dublin, Ireland, and its U.S. headquarters in Radnor, Pennsylvania. For more information, please visit www.adaptpharma.com.
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[ii] Centers for Disease Control Wonder Database Multiple Cause of Death MCD – ICD-10 Codes: T40.1 (Heroin), T40.2 (Other opioids), T40.3 (Methadone), T40.4 (Other synthetic narcotics), 2013.
[iii] Substance Abuse and Mental Health Services Administration. SAMHSA Opioid Overdose Prevention Toolkit. HHS Publication No. (SMA) 14-4742. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2014.
[iv] U.S. Food and Drug Administration. Priority Review. Available at:www.fda.gov/ForPatients/Approvals/Fast/ucm405405.htm.