Adapt Pharma Limited (Adapt Pharma), a privately-held pharmaceutical company, announced that the US 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).
Almost 24,500 American lives were lost to opioid overdose in 2013, or an average of one life every 21 minutes. The majority of those deaths happened in people’s homes.
“Narcan nasal spray was designed as a ready-to-use option to facilitate the administration of naloxone wherever an opioid overdose 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. 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).
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.
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.