FDA has reportedly put an OTC version of naloxone nasal spray (Narcan—Emergent BioSolutions) on the fast track to approval
Currently, the FDA is fast tracking the approval of an over the counter drug called Narcan, which is an opioid antagonist used to prevent an overdose of heroin or opiates. This new drug, which is manufactured by Emergent BioSolutions, may be the first to reach the market.
Narcan's safety and effectiveness
During an opioid overdose, Narcan works to reverse the negative effects of the drug. While it is not effective in every case, it has been shown to be effective in a number of instances.
A nasal spray, Narcan contains an active ingredient called naloxone, which reverses the effects of opioids. It is given to people who are at risk of overdose, usually by a loved one.
When Narcan is given in an emergency situation, it will start working within a matter of minutes. The drug will also be effective at preventing respiratory depression, which is the result of a person's breathing becoming slow and shallow. This means that you should call 911 as soon as possible after taking a dose.
Naloxone can be given via an auto injector or nasal spray. It can be purchased at several retail pharmacies. In some cities, free Narcan is available. It can be used alone or in combination with other medications.
Before you use Narcan, you should talk to your doctor. You should also check with your local government regarding laws regarding overdosing.
You should also keep in mind that Narcan can cause side effects such as vomiting, stiffness, and overactive reflexes. These effects may only be mild and will subside on their own in a few days.
Access barriers to naloxone
Despite naloxone being widely available, access barriers continue to limit its distribution and use. These barriers are based on a number of factors, including social, policy and physical environments. To better understand these factors, researchers conducted a study that examined the availability and dispensing of naloxone, as well as assessing the attitudes of pharmacists and consumers to pharmacy naloxone provision.
A cross-sectional survey was administered via telephone to identify barriers to naloxone prescribing and distribution. Inductive content analysis was used to summarize the survey responses. The results showed that naloxone users, naloxone prescribing providers, and pharmacists reported a range of barriers, with the most common cited being a lack of education about naloxone and its efficacy, as well as stigma and legality. Increasing public awareness of naloxone's role in reducing opioid-related harms may facilitate further naloxone distribution.
In addition to providing naloxone, emergency responders also have an important role to play. The World Health Organization (WHO) recommends naloxone availability to persons who are at risk of overdose, as well as friends and family. This recommendation is in keeping with the goal of reducing opioid-related deaths.
The naloxone distribution programme should be designed to maximise availability, while minimising stigma. This includes ensuring naloxone distribution locations are accessible in different community settings. This can be achieved through a variety of approaches, including needle syringe programs, as well as through non-medical services.
Emergent BioSolutions' product may be the first to reach the market
Earlier this month, Emergent BioSolutions announced plans to speed up the approval process for their Narcan nasal spray. The company's supplemental New Drug Application (NDA) has received priority review from the FDA. This means the agency plans to make a decision about the application in three to four months. This could allow the naloxone to be available over the counter in late March of next year.
The company says that a product based on naloxone would be a vital tool to combat the growing opioid epidemic. It says that the drug is widely used by first responders and laypeople alike to reverse opioid overdoses. It's also a safe and effective harm reduction tool.
The FDA has approved a preliminary opinion indicating that an OTC naloxone nasal spray could be safe without medical supervision. It is the first intranasal form of naloxone to receive approval.
The application is likely to face competition from other naloxone providers. In addition, a new start-up company announced plans to seek over-the-counter approval for their naloxone nasal swab.
A recent study suggests that a nasal swab of naloxone reversed opioid overdoses more quickly than a nasal spray. The FDA is still collecting additional data. It has also signaled support for manufacturers of naxalone products.
If the application is approved, it may be the first naloxone product to be available over the counter. This could increase naloxone's access to those in need and reduce stigma associated with asking for a prescription.
If you or someone you love is struggling with substance abuse, contact an addiction treatment center for help.
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