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Opioid Overdose Nasal Spray Cleared for FDA Review

Spilled pills


29 July 2015. Indivior plc, a pharmaceutical company in the U.K. specializing in addiction therapies, received notice that the U.S. Food and Drug Administration accepted the company’s new drug application and is beginning review of Indivior’s opioid overdose treatment formulated as a nasal spray. The FDA also granted Indivior, in Slough, U.K., priority review status for the nasal spray, which is expected to expedite its review.

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.

The treatment candidate 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 the standard treatment for an opioid overdose.

Indivior is a developer of treatments for opioid dependence or overdose, including current products with naloxone. The nasal spray contains naloxone, but formulated to be quickly absorbed through mucous membranes in the nose. The drug is expected to be packaged in pre-measured single-dose containers, designed for use by people with minimal training to help overdose victims in an emergency. The company says clinical trials of the nasal spray are completed.

FDA designates new drugs for priority review if they’re considered significant improvements in safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. Priority reviews make it possible for FDA to complete its review in 6 months compared to a typical 10 month standard review. However, priority reviews do not change the evaluation standards, nor do they affect the length of clinical trial periods.

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