UPDATED: Third time's the charm: Adamis nabs approval of high-dose naloxone injection after two CRLs
If at first you don’t succeed, and at second you don’t succeed, try, try again.
That’s been the unofficial mantra for Adamis Pharmaceuticals’ high dose naloxone injection, which received two CRLs in the span of a year between the Novembers of 2019 and 2020. But on Monday, word came through that the FDA approved the drug on Adamis’ third attempt, giving doctors another tool to treat individuals who overdose on opioids.
The drug will be marketed as Zimhi, and there’s no word yet on the price. An Adamis spokesperson told Endpoints News via email that the drug will be priced by US WorldMeds which will set it “competitively.”
“The higher intramuscular doses of naloxone in ZIMHI should result in more rapid and higher levels of naloxone in the systemic circulation, which in turn, should result in more successful resuscitations,” said Jeffrey Galinkin, former FDA adcomm member and paid Adamis consultant, in a prepared statement. He added the drug will particularly help the rising number of fentanyl-related overdoses.
Investors welcomed the news for the small-cap player, sending Adamis shares $ADMP up 17% in early Monday trading to $1.33 per share. The stock price has yet to recover from a February 2019 rejection, however, when regulators shot down a pitch for an erectile dysfunction drug.
Naloxone, generally sold under the brand name Narcan, has proven a key element to trying to curb the opioid epidemic in the US, being used by first responders and emergency room doctors to immediately intervene during an overdose. Developed by Adapt Pharma and now owned by Emergent BioSolutions, Narcan is available at a 40% discount to state and local governments and non-profit organizations.
Adamis, meanwhile, centers its strategy on offering lower-cost alternatives to drugs that are already out there. Narcan and other naloxone-based products like Evzio generally use less of the drug than Zimhi’s 5 mg/0.5 mL dose.
For Zimhi, the biotech ran into manufacturing headwinds both times it received rejections, but the FDA has ostensibly been satisfied with the company’s remedies. Prior to the second CRL, Adamis had entered into a distribution agreement for the program that would have, pending approval, totaled up to $26 million in upfront cash and milestone payments. It’s unclear whether that agreement will take effect with Monday’s news.
Adamis’ main product is an epinephrine injectable called Symjepi, which is used to treat allergic reactions and anaphylactic shock similar to Mylan’s blockbuster EpiPen. Researchers formulated a way to use the same delivery system for Zimhi as Symjepi, and the biotech is also developing treatments for a range of respiratory diseases, such as Covid-19, influenza, asthma and COPD.
Previously, the FDA had also approved a generic version of Narcan nasal spray to be used by those without medical training in April 2019.
This article has been updated to include Zimhi pricing information and to clarify that Jeffrey Galinkin is a paid consultant for Adamis.