Thursday, April 25, 2024
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) has unveiled its Over the Counter (OTC) Naloxone Hydrochloride (Naloxone HCI) Nasal Spray, USP, 4mg, after securing Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA). This nasal spray, produced domestically by Amneal, serves as a generic alternative to the widely used OTC NARCAN® HCI Nasal Spray, crucial for treating opioid overdoses triggered by substances like heroin, fentanyl, and prescription opioids.
The Co-Chief Executive Officers, Chirag and Chintu Patel, expressed their satisfaction in aiding the ongoing public health crisis by making naloxone nasal spray available without prescription and at an affordable cost. They underscored Amneal's commitment to assisting communities and families in averting further tragedies associated with opioid overdose.
Statistics indicate that a significant portion of drug overdose fatalities involve illicit synthetic opioids, particularly fentanyl, surpassing other causes of death among individuals under 50. According to the Centers for Disease Control and Prevention, almost half of overdose deaths occur in the presence of another person who has the potential to intervene.
Amneal's Naloxone HCI Nasal Spray is now available, aiming to expand access to this emergency treatment option. Commercial sales data from IQVIA® reveals substantial annual sales for NARCAN® Naloxone HCl Nasal Spray, with additional procurement by U.S. states and municipalities.
Naloxone Nasal Spray is designed to swiftly counteract the effects of opioid overdose by binding to opioid receptors, restoring normal breathing within minutes. It contains the same active ingredient and dosage as NARCAN® Naloxone HCI Nasal Spray and is user-friendly and safe for use even when opioids are absent.
Acknowledging the symptoms that some individuals may experience upon waking, such as shaking or nausea, the product ensures users are prepared for potential reactions.
The opioid crisis, declared a national public health emergency in 2017, remains a top priority for the U.S. government and Congress. Since 2000, opioid-related overdoses have claimed the lives of approximately one million Americans, primarily due to the misuse of prescription pain medication and the prevalence of fentanyl-laced drugs. In 2022, opioid-related deaths in the U.S. surpassed those from motor vehicle accidents, underscoring the urgency of addressing this crisis.
Source: businesswire.com
