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FDA Approves Nasal Spray for Opioid Overdose

Narcan nasal spray

Narcan nasal spray (Adapt Pharma Ltd)

20 November 2015. The U.S. Food and Drug Administration this week approved the first formulation of a current drug to treat opioid overdose in nasal spray form. The Narcan nasal spray is made by Adapt Pharma Ltd., a company headquartered in Dublin, Ireland.

Opioids work by reducing the intensity of pain signals to the brain, particularly regions of the brain controlling emotion, which reduces effects of the pain stimulus. Examples of leading opioid prescription pain medications are hydrocodone, oxycodon, morphine, and codeine.

Abuse of opioid pain killers is described by Centers for Disease Control and Prevention as a growing epidemic, fueled in part by growing numbers of prescriptions written for pain killing drugs. CDC reports that in 2012, physicians in the U.S. wrote 259 million prescriptions for pain killers, enough for one bottle of pills for every adult in the country. As of July 2014, according to the CDC, 46 people die each day in the U.S. from an overdose of prescription pain killers. The 10 states with the highest rates of prescriptions for pain killers, says CDC, are in the South.

Narcan nasal spray contains the opioid overdose antidote naloxone, now administered by physicians or emergency medical technicians as an injection, but can also be given by family members or home health care givers. Naloxone activates and binds to opioid receptors in the brain to reverse the effects of natural and synthetic opioids, and is considered a standard treatment for an opioid overdose.

FDA says naloxone is already being used as an unapproved nasal spray by combining the drug with an atomizer. The agency says Narcan provides a consistent pre-measured dose of the drug, and can be used directly out of the box and administered by non-professionals, such as family members, as well as clinicians and first responders. Clinical trials of Narcan show a single dose delivered in one nostril provide as much or more naloxone as a conventional intramuscular injection, and works about as quickly.

Narcan received both fast-track and priority review from FDA, which provides for expedited review of new drugs that address unmet serious conditions, and offer improvements in safety or effectiveness over current drugs. FDA said it completed its review in less than four months.

Adapt Pharma says it arranged with the Clinton Health Matters Initiative to make the Narcan nasal spray available at a discounted price to group purchasers in law enforcement and first responders, public health, educational institutions, and community organizations.

In July 2015, as reported in Science & Enterprise, FDA designated another nalaxone nasal spray for priority review, made by Indivior, in Slough, U.K.

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