18 March 2019 - - The US Food and Drug Administration has accepted for review the company's New Drug Application for its higher naloxone injection product candidate for the treatment of opioid overdose, US-based Adamis Pharmaceuticals Corp. (NASDAQ: ADMP) said.

On March 14, 2019, Adamis received FDA correspondence relating to the company's NDA stating that the Agency had completed its filing review and had determined that the NDA was sufficiently complete to permit a substantive review.

The FDA further provided a target agency action date of October 31, 2019.

Naloxone is an opioid antagonist used to treat narcotic overdoses.

Naloxone, which is generally considered the drug of choice for immediate administration for opioid overdose, blocks or reverses the effects of the opioid, including extreme drowsiness, slowed breathing, or loss of consciousness. Common opioids include morphine, heroin, tramadol, oxycodone, hydrocodone and fentanyl.

According to statistics published by the Centers for Disease Control and Prevention (CDC) in 2017, drug overdoses resulted in approximately 72,000 deaths in the United States greater than 195 deaths per day.

Drug overdoses are now the leading cause of death for Americans under 50 and the proliferation of more powerful synthetic opioids, like fentanyl and its analogues, could result in future increases in the number of deaths resulting from opioid overdoses.

The current epidemic of drug overdoses is killing people at a faster rate than the HIV epidemic at its peak.
In December 2018, the joint meeting of the Anesthetic and Analgesic Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted in favour of adding labeling language that recommends co-prescription of naloxone for all or some patients prescribed opioids.

Medicare has also recommended co-prescribing naloxone with opioids under certain conditions. These recommendations could significantly increase the naloxone market.

Adamis Pharmaceuticals is a specialty biopharmaceutical company primarily focused on developing and commercializing products in various therapeutic areas, including respiratory disease and allergy.

The company's SYMJEPI (epinephrine) Injection 0.3mg and SYMJEPI (epinephrine) Injection 0.15mg products were approved by the FDA for use in the emergency treatment of acute allergic reactions, including anaphylaxis.

Adamis has announced a distribution and commercialisation agreement with Sandoz, a division of Novartis Group, to market Symjepi in the US.

Adamis is developing additional products, including a sublingual tadalafil product candidate for the treatment of erectile dysfunction, a naloxone injection product candidate for the treatment of opioid overdose, and a metered dose inhaler and dry powder inhaler product candidates for the treatment of asthma and COPD.

The company's subsidiary, US Compounding, Inc., compounds sterile prescription drugs, and certain nonsterile drugs for use by hospitals, clinics and surgery centers throughout most of the United States.