Adamis shares slump as FDA declines to approve opioid overdose treatment

By Shivani Singh

(Reuters) – Adamis Pharmaceuticals Corp (O:) said on Monday the U.S. Food and Drug Administration declined to approve its opioid overdose treatment, Zimhi, sending its shares plunging 56%.

In a so-called complete response letter (CRL), the FDA questioned the treatment’s chemistry, manufacturing and controls process, but not its safety or effectiveness, the company said.

The drug is a naloxone pre-filled single dose syringe used for emergency treatment of known or suspected opioid overdose, and investors hoped the treatment would help the San Diego-based company reduce its reliance on its emergency allergy shot, Symjepi.

Adamis Pharmaceuticals had revenue of about $5.9 million in the third quarter, a 54% jump from a year earlier on Symjepi demand.

Maxim (NASDAQ:) Group analyst Jason McCarthy in a note, ahead of FDA’s decision, estimated Zimhi to bring in peak sales of $70.8 mln in 2028.

“We believe the comments and recommendations stated in the CRL are manageable and plan to fully cooperate with the FDA,” Adamis Chief Executive Dennis Carlo said in a statement.

The company said it will request a meeting with the FDA “as soon as reasonably possible” and plans to resubmit its application for approval.

Adamis is seeking to use Zimhi, which delivers high doses of naloxone, as part of the fight against the opioid crisis in the United States.

Opioids were involved in nearly 400,000 overdose deaths in the United States from 1999 to 2017, according to the U.S. Centers for Disease Control and Prevention.

The U.S. Department of Health and Human Services last December had recommended prescribing or co-prescribing naloxone to high-risk patients for opioid overdose.

The company’s shares were at 54 cents in morning trading. They had fallen 44% this year, through Friday’s close.

Disclaimer: Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. All CFDs (stocks, indexes, futures) and Forex prices are not provided by exchanges but rather by market makers, and so prices may not be accurate and may differ from the actual market price, meaning prices are indicative and not appropriate for trading purposes. Therefore Fusion Media doesn`t bear any responsibility for any trading losses you might incur as a result of using this data.

Fusion Media or anyone involved with Fusion Media will not accept any liability for loss or damage as a result of reliance on the information including data, quotes, charts and buy/sell signals contained within this website. Please be fully informed regarding the risks and costs associated with trading the financial markets, it is one of the riskiest investment forms possible.