Adapt Pharma submits NDA to FDA for NARCAN® (Naloxone) Nasal Spray

July 27, 2015

DUBLIN, IRELAND – July 27th, 2015 – Adapt Pharma Limited (Adapt Pharma) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Narcan (naloxone) Nasal Spray, an investigational drug intended to treat opioid overdose. 

Narcan Nasal Spray has been granted Fast Track Designation by the FDA.  Within 60 days of the submission date, the FDA will determine whether it will accept the application for review as filed.  Narcan Nasal Spray was developed in collaboration with the National Institutes on Drug Abuse (NIDA).

Background about the opioid overdose epidemic

There is a rapidly growing opioid overdose epidemic in communities across America.  Centers for Disease Control and Prevention (CDC) data indicates that almost 24,500 lives were lost to opioid overdose in 2013 and 76% of these deaths occurred in a non-medical setting, most frequently at home.  Over two thirds of these deaths were due to prescription opioids, a commonly prescribed class of pain medication. 

About naloxone

While naloxone has been FDA approved as the standard opioid overdose treatment for almost 45 years, currently all FDA approved formulations are injectable.  There is a broad consensus, including the American Medical Association, CDC and the American Public Health Association, supporting expanded distribution and availability of naloxone in community settings, as a key element to address this human tragedy.

About Narcan® (naloxone) Nasal Spray

Adapt Pharma developed Narcan Nasal Spray in response to calls for new easy-to-use formulations of naloxone for use in the communities and homes where the majority of overdose related deaths occur. 

Seamus Mulligan, Chairman and CEO of Adapt Pharma, commented, “If FDA approved, Narcan Nasal Spray would allow for the administration of naloxone – the standard opioid overdose treatment – in an easy to use, needle-free, nasal spray formulation. We believe this would represent an important new tool to quickly respond to an opioid overdose emergency with this potentially life-saving medicine.”

About opioid overdose

The number of opioid overdose related deaths continues to increase. Data from CDC WONDER database indicates opioid overdose led to the loss of almost 24,500 lives in America in 2013, a four-fold increase since 1999. Additionally, the Drug Abuse Warning Network (DAWN), a public health surveillance system managed by the Substance Abuse and Mental Health Services Administration (SAMHSA), estimated that in 2011 there were over 740,000 emergency department visits involving the non-medical use of prescription opioids and heroin.  With the majority of opioid overdose related deaths occurring in a non-medical setting, there is a need for more user friendly formulations of naloxone suitable for use in the community.

About Adapt Pharma

Adapt Pharma Limited is a privately held pharmaceutical company committed to positively impacting the lives of patients with specialist medical conditions. 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

Media Contact

Megan Griffin-Jagassar, Consitor Health, Phone: 202-530-4549

Email: megan.griffin-jagassar@consitorhealth.com

OR:

Irish Media: Ray Gordon, Gordon MRM, Phone +353-87-241-7373

Email:  ray@gordonmrm.ie

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 or to any of the other ingredients.

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, 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 some patients, there may be aggressive behavior upon abrupt reversal of an opioid overdose. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated and may also include 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.

Adverse Reactions: The following adverse reactions were observed in a NARCAN® Nasal Spray clinical study: increased blood pressure, constipation, toothache, muscle spasms, musculoskeletal pain, headache, nasal dryness, nasal edema, nasal congestion, nasal inflammation, rhinalgia, and xeroderma.

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.

See Instructions for Use and full prescribing information in the use of this product, available here: https://www.narcan.com/pdf/NARCAN-Prescribing-Information.pdf .

Additional information, including full prescribing information for NARCAN® Nasal Spray, and important safety information and instructions for use, is also available at www.NARCAN.com.