FDA approves drug for emergency treatment of known or suspected opioid overdoses

The FDA has approved the 2-mg dosage of nasal spray Narcan for ready-to-use emergency treatments of suspected or known opioid overdose, including prescription opioid painkiller-, fentanyl-, carfentanil- and heroin-related overdose in patients who are dependent on opioids, according to Adapt Pharma Inc., the nasal spray’s manufacturer.

A press release also stated Narcan (naloxone hydrochloride, Adapt Pharma Inc.) is approved for use in opioid-dependent patients at risk of severe opioid withdrawal in incidents where “there is a low risk for accidental or intentional opioid exposure by household contacts.”

The suspected or known opioid overdoses are manifested by central nervous depression, respiratory depression or both, the release said, which also emphasized Narcan is not a replacement for emergency medical care and the drug should be administered every 2 minutes to 3 minutes until emergency help arrives.

“This new 2-mg dosage strength provides a new dosing option for a specific opioid dependent patient population at risk of an accidental opioid overdose,” Thom Duddy, executive director, communications, Adapt Pharma Inc., told Healio Family Medicine.

A 4-mg dosage version of the drug was approved by the FDA in 2015 and was launched in February of last year. According to Duddy, both dosages are “…simple, ready-to-use and needle free.”

Adverse events in a clinical study on the drug included xeroderma, rhinalgia, nasal inflammation, congestion, edema and dryness, headache, musculoskeletal pain, muscle spasms, toothache, constipation, and increased blood pressure.

According to Ruddy, the company will provide additional information on the access and availability of the product once it launches, but he did not indicate when that launch would occur.

“We will make an announcement about launch timing of the 2-mg once finalized,” he said.

Recently released data from several federal agencies showed ED visits, inpatient stays and other medical emergencies connected to opioid use continue to rise.

Citing the “epidemic of overdose deaths,” the CDC issued guidelines for primary care physicians and other medical professionals for opioid prescriptions last year.

Several other recent approvals by the FDA are also targeted to address the ongoing opioid abuse crisis, with new pain relief agents that are manufactured in a manner to limit abuse. Last week, it approved Vantrela ER (hydrocodone bitartrate, Teva Pharmaceuticals), an extended-release tablet for patients with severe pain that necessitates long-term, around-the-clock treatment. Earlier this month, the FDA approved Arymo ER (morphine sulfate, Egalet) for patients with severe chronic pain. Last August, the agency approved Pfizer’s Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) for the same population.

Reference:

http://adaptpharma.com/adapt_press_release/january-25-2017-narcan-nasal-spray-2mg-approved-by-us-food-and-drug-administration/