Adapt Pharma Announces NARCAN® coverage with California’s Medi-Cal Program

October 5, 2016

Dublin, Ireland – October 5, 2016 – Effective October 1, 2016, the Medi-Cal Fee-For-Service program provides unrestricted, $0 co-pay access to NARCAN® Nasal Spray for its beneficiaries. As a result of this decision, beneficiaries can now obtain NARCAN® Nasal Spray from pharmacists across the state within 24 hours, establishing an unprecedented level of access and coverage.

This announcement builds on California’s steady commitment to improving statewide opioid safety. Most impressively, the state’s co-prescribing recommendations for providers, pharmacists and county mental health plans that encourage the use of naloxone for all patients exposed to opioids.

“California continues to pave the way for educating patients, collaborating with physicians and improving community access to this potentially life-saving medication,” said Seamus Mulligan, Chairman and CEO of Adapt Pharma. “The Medi-Cal Fee-For-Service program’s decision to provide restriction-free, no-cost access of NARCAN® Nasal Spray to its beneficiaries is a tangible and measurable achievement in the state’s broader initiative to combat this epidemic – and ultimately save the lives of Californians vulnerable to opioid-related overdose.”

“Adapt Pharma places affordability and access of NARCAN® Nasal Spray as an important priority,” noted Mulligan. “This announcement, along with our partnerships with all major wholesalers, distributors, and retail pharmacies, will ensure broad access to community-ready naloxone in California and throughout the country.”

NARCAN® Nasal Spray is the first and only FDA-approved naloxone in a nasal spray for the emergency treatment of prescription opioid, fentanyl and heroin-related overdose. It is now available as a ready-to-use, needle-free, 4 mg concentrated dose of naloxone in a single spray. As the first and only FDA-approved naloxone nasal spray, NARCAN® Nasal Spray provides a ready-to-use alternative to currently available opioid overdose emergency treatments. NARCAN® Nasal Spray is not a substitute for emergency medical care, and repeat applications may be necessary. Seek emergency medical assistance immediately after initial use, keeping the patient under continued surveillance.

ABOUT Medi-Cal

Medi-Cal covers children, families, low-income adults, current and former foster children, pregnant women, seniors and persons with disabilities. The program’s comprehensive benefits, no different than private insurance, include preventive services, medical, dental, mental health, vision, substance abuse treatment and long-term care services and supports. Medi-Cal also supports rural hospitals, trauma centers and other “safety net” services and providers that care for patients who otherwise would not be able to afford or access care.

For more information, please visit the California Department of Health Care Services (DHCS) website.

Please see Indications and Important Safety Information below.

ABOUT NARCAN® (naloxone HCl) NASAL SPRAY

NARCAN® Nasal Spray is 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. Always seek emergency medical assistance in the event of a suspected, potentially life-threatening opioid emergency after administration of the first dose of NARCAN® nasal spray.

If the desired response is not obtained after 2 or 3 minutes, administer an additional dose of NARCAN® Nasal Spray using a new NARCAN® Nasal Spray. If the patient responds to NARCAN® Nasal Spray and relapses back into respiratory depression before emergency assistance arrives, administer an additional dose and continue surveillance of the patient. If there is still no response and additional doses are available, administer additional doses of NARCAN® Nasal Spray every 2 to 3 minutes using a new NARCAN® Nasal Spray with each dose until emergency medical assistance arrives. Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.

Please see Indications and Important Safety Information below. 

Please see full prescribing information for NARCAN® Nasal Spray, available at http://www.NARCAN.com/pdf/NARCAN-Prescribing-Information.pdf

AVAILABILITY OF NARCAN® NASAL SPRAY

NARCAN® Nasal Spray is available to individuals in leading retail pharmacies.

Qualifying group purchasers may source NARCAN® Nasal Spray directly from wholesalers and distributors. To place a pre-order immediately or for assistance in sourcing NARCAN® Nasal Spray please contact Adapt Pharma’s dedicated Customer Service Team at 844-4-NARCAN® (844-462-7226) or email customerservice@adaptpharma.com.

NARCAN® NASAL SPRAY INDICATIONS AND IMPORTANT SAFETY INFORMATION

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, available here: http://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.

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.

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 is in Dublin, Ireland and its U.S. headquarters is in Radnor, Pennsylvania. For more information, please visit www.adaptpharma.com.

For Media Inquiries

Thom Duddy, Adapt Pharma
Executive Director, Communications
Mobile: 484-532-5470
Email: thomas.duddy@adaptpharma.com