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). 

Almost 24,500 American lives were lost to opioid overdose in 2013, or an average of one life every 21 minutes.[i] The majority of those deaths happened in people’s homes.[ii]

“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]

About Naloxone

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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[i]   Centers for Disease Control and Prevention: NCHS Data Brief Number 190, March 2015. Available at:www.cdc.gov/nchs/data/databriefs/db190.htm#ref2.

[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.

Indications

NARCAN® (naloxone hydrochloride) Nasal Spray is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. NARCAN® Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present.

NARCAN® Nasal Spray is not a substitute for emergency medical care.

 

IMPORTANT SAFETY INFORMATION

NARCAN® Nasal Spray is contraindicated in patients known to be hypersensitive to naloxone hydrochloride.

Seek emergency medical assistance immediately after initial use, keeping the patient under continued surveillance.

Risk of Recurrent Respiratory and CNS Depression: Due to the duration of action of naloxone relative to the opioid, keep the patient under continued surveillance and administer repeat doses of naloxone using a new nasal spray with each dose, as necessary, while awaiting emergency medical assistance.

Risk of Limited Efficacy with Partial Agonists or Mixed Agonists/Antagonists: Reversal of respiratory depression caused by partial agonists or mixed agonists/antagonists, such as buprenorphine and pentazocine, may be incomplete. Larger or repeat doses may be required.

Precipitation of Severe Opioid Withdrawal: Use in patients who are opioid dependent may precipitate opioid withdrawal characterized by body aches, diarrhea, increased heart rate (tachycardia), fever, runny nose, sneezing, goose bumps (piloerection), sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated and may be characterized by convulsions, excessive crying, and hyperactive reflexes. Monitor for the development of opioid withdrawal.

Risk of Cardiovascular (CV) Effects: Abrupt postoperative reversal of opioid depression may result in adverse CV effects. These events have primarily occurred in patients who had pre-existing CV disorders or received other drugs that may have similar adverse CV effects. Monitor these patients closely in an appropriate healthcare setting after use of naloxone hydrochloride.

The following adverse reactions were observed in a NARCAN Nasal Spray clinical study: increased blood pressure, musculoskeletal pain, headache, nasal dryness, nasal edema, nasal congestion, and nasal inflammation.

See Instructions for Use and full prescribing information in the use of this product.

To report SUSPECTED ADVERSE REACTIONS, contact Adapt Pharma, Inc. at 1-844-4NARCAN (1-844-462-7226) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.