The Food and Drug Administration has approved the first nasal spray variant of the opioid-overdose drug naloxone hydrochloride.
Marketed in the United States as Narcan by Adapt Pharma, a partner of Lightlake Therapeutics, the nasal spray is known to stop or, in some cases, reverse the effects of opioid overdosing in patients. Narcan is the first naloxone hydrochloride nasal spray approved by the FDA.
“Combating the opioid abuse epidemic is a top priority for the FDA,” Dr. Stephen Ostroff, FDA acting commissioner, said in a statement released with the Nov. 18 approval announcement. “We cannot stand by while Americans are dying. While naloxone will not solve the underlying problems of the opioid epidemic, we are speeding to review new formulations that will ultimately save lives that might otherwise be lost to drug addiction and overdose.”
The nasal spray itself is available only with a prescription, and is safe for use by both adults and children, according to the FDA.
The spray delivers a dose of 4 mg naloxone in a single 0.1-mL nasal spray, which comes in a ready-to-use, needle-free device, according to Adapt Pharma. Dosage varies for each individual and should be determined by physicians.
Administration of Narcan, which is sprayed into one nostril while the patient is lying on his or her back, does not require special training and can be performed by anyone.
Narcan’s approval comes less than 4 months after the FDA granted the medication a fast-track designation and priority review status, both of which are meant to expedite the review and approval processes for drugs that “demonstrate the potential to address an unmet medical need” and “offer a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition,” according to the FDA’s approval statement.
Adverse events associated with opiate withdrawal have been noted in Narcan patients. Specifically, the FDA warned that body aches, diarrhea, tachycardia, fever, piloerection, nausea, nervousness, abdominal cramps, weakness, and increased blood pressure, among other conditions, are all possible side effects of Narcan.
“Opioid overdose is responsible for the deaths of thousands of Americans in communities throughout the country, leaving a trail of devastation for friends and families,” Seamus Mulligan, Adapt Pharma’s chairman and CEO, said in a statement. “This new device makes naloxone readily available for emergency use by a friend, family member, or caregiver, as well as offering an alternative treatment option for first responders and health care providers.”
Narcan’s approval is one step of many that must be taken to adequately address and ultimately end the problem of opioid abuse in the United States, cautioned Dr. Peter Friedmann, chief research officer at Baystate Health in Springfield, Mass.
“[Narcan] is just addressing overdose; we need more and better medications for treating addiction, we need more physicians and clinicians who are skilled in using these medications,” said Dr. Friedmann. “Given the ongoing crisis of deaths from opioid overuse, this expands the options that physicians, pharmacies, and community distribution programs can use to reduce these deaths.”
Dr. Friedmann also voiced his concern regarding the pricing of Narcan. Making the drug affordable is crucial to its success at successfully treating opioid overuse, he said.
“Right now, nasal atomizers with syringes are used off label, and the prices have been going up with increasing demand,” he said. “But [Narcan] is a commercial product based around what is essentially a generic medication, so [I] hope it’s priced at a price point that’s accessible to the great majority of patients and their families who are facing addiction, many of whom don’t have huge means.”
Dr. Friedmann said that he hopes addiction medicine becomes a more attractive field for medical students and residents. It’s important for future physicians to know how to properly treat patients of addiction and administer drugs safely and effectively, he said.
“Addiction medicine is on the cusp of full recognition as a medical specialty, and we need people to go into that field to teach patients, medical students, and residents how to treat people with addiction,” Dr. Friedmann said. At the current rate, “we’re never going to have enough, so we need generalists to take this on.”