Opiant Receives FDA Fast Track Designation for OPNT003, Nasal Nalmefene, for Treatment of Opioid Overdose

Rhea-AI Summary

Opiant Pharmaceuticals has received Fast Track Designation from the FDA for its investigational drug OPNT003, a nasal formulation of nalmefene aimed at treating opioid overdoses. This designation highlights the drug's potential to significantly impact the public health crisis of rising opioid overdose deaths, particularly driven by potent synthetic opioids like fentanyl. The Fast Track status allows for more frequent communication with the FDA and a potential rolling submission for its New Drug Application. OPNT003 shows promise based on recent pharmacokinetic studies.

Positive

• Fast Track Designation granted for OPNT003 by the FDA.
• Potential to significantly address the opioid overdose crisis.
• Promising results from recent pharmacokinetic studies.

Negative

• None.

• Fast Track Designation further underscores the potential for OPNT003 to represent a major advance in the treatment of opioid overdose as opioid overdose deaths surge¹
  
  
• This designation enables early and frequent communication with the FDA, in addition to the potential for a rolling submission of NDA application²
  

SANTA MONICA, Calif., Nov. 04, 2021 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. (“Opiant”) (NASDAQ: OPNT), a company advancing medicines to better treat addictions and drug overdose, today announced that the U.S. Food and Drug Administration (“FDA”) has granted fast track designation for OPNT003, nasal nalmefene, its investigational treatment for opioid overdose.

In July, the Company reported positive results from a confirmatory pharmacokinetic (“PK”) study comparing OPNT003 to intramuscular nalmefene injection³. The characteristics OPNT003 exhibited in this study, coupled with nalmefene’s five-fold higher affinity compared to naloxone⁴, demonstrate its promise as a potential new treatment. OPNT003 is currently being studied in an ongoing pharmacodynamic (“PD”) study comparing it to nasal naloxone⁵. Both PK and PD data will form the basis of a New Drug Application (“NDA”) submission using the 505(b)(2) regulatory pathway.

“Opioid overdoses in the United States are a public health crisis with rates at the highest level in history and particularly powerful synthetic opioids like fentanyl, being the main driver,” said Dr. Roger Crystal, President and CEO, Opiant. “The designation of Fast Track status by the FDA underscores the potential for OPNT003 to represent a major advance in opioid overdose treatment that can help communities better respond to this escalating crisis. Opiant is focused on advancing the OPNT003 development program as rapidly as possible and the granting of Fast Track designation represents significant additional support toward this objective.”

Synthetic opioids such as fentanyl are significantly more potent, have a very rapid onset, and a longer duration of action compared to heroin and prescription opioids. Synthetic opioids have created a much more dangerous environment for individuals that are using drugs, and not just those that use opioids. Fentanyl and related synthetic opioids have made their way into many substances sold illegally, including cocaine, methamphetamine and counterfeit pills, and is responsible for the deaths of thousands of Americans. Synthetic opioids have been found present in as many as 80% of overdose deaths¹. Proving more resistant to reversal by standard doses of naloxone⁶, the public health threat posed by synthetic opioids prompted leadership at the National Institutes of Health (NIH) to call for the development of “…stronger, longer-acting formulations of antagonists⁷…”

Fast Track is an FDA process designed to facilitate the development and expedite the review of potential therapies that seek to treat serious conditions and fill an unmet medical need. Programs with Fast Track designation may benefit from early and frequent communication with the FDA, in addition to a potential rolling submission of the marketing application². For more information on Fast Track designation, please visit the FDA's website, available at https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track.

About Opiant Pharmaceuticals, Inc. 
Opiant Pharmaceuticals, Inc., the company that developed NARCAN® Nasal Spray, is building a leading franchise of new medicines to combat addictions and drug overdose. For more information visit: www.opiant.com.

Forward-Looking Statements
This press release contains forward-looking statements, including statements for OPNT003’s potential as an opioid overdose reversal agent. These statements relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our or our industry's actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed, implied or inferred by these forward-looking statements, and among other things, our ability to maintain cash balances and successfully commercialize or partner our product candidates currently under development. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "could," "would," "expects," "plans," "intends," "anticipates," "believes," "estimates," "predicts," "projects," "potential," or "continue" or the negative of such terms and other comparable terminology. These statements are only predictions based on our current expectations and projections about future events. You should not place undue reliance on these statements. Actual events or results may differ materially. In evaluating these statements, you should specifically consider various factors. Additional factors that could materially affect actual results can be found in our Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on March 4, 2021, including under the caption titled "Risk Factors."  These and other factors may cause our actual results to differ materially from any forward-looking statement. We undertake no obligation to update any of the forward-looking statements after the date of this press release to conform those statements to reflect the occurrence of unanticipated events, except as required by applicable law.

References:

1. F. Ahmad et al. Provisional drug overdose death counts. National Center for Health Statistics (2021). https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm
2. U.S. Food and Drug Administration (FDA). Fast Track. Available from: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track.
3. Opiant Press Release. Link.
4. J. Cassel, et al. Alvimopan binding to the μ opioid receptor: Comparative binding kinetics of opioid antagonists. European Journal of Pharmacology, 520 (2005), pp. 29-36
5. ClinicalTrials.gov (NCT04828005) Link.
6. R. Moss, et al. Higher doses of naloxone are needed in the synthetic opioid era. Substance Abuse Treatment, Prevention, and Policy, 14 (2019), p. 6
7. Volkow N & Collins F. The role of science in addressing the opioid crisis. N. Engl. J. Med 377, 391–394 (2017).
   

For Media and Investor Inquiries:
Ben Atkins, Opiant
(310) 598-5410
batkins@opiant.com

FAQ

What is the Fast Track Designation granted to OPNT003?

The Fast Track Designation is an FDA process that expedites the development and review of drugs that treat serious conditions and fulfill unmet medical needs.

How does OPNT003 compare to traditional naloxone in terms of effectiveness?

OPNT003 has shown a five-fold higher affinity compared to naloxone, indicating a potentially stronger effect in reversing opioid overdoses.

What is the significance of the recent pharmacokinetic study for OPNT003?

The study demonstrated positive results that support OPNT003's potential as a new treatment for opioid overdose, paving the way for a New Drug Application submission.

How does OPNT003 help in the current opioid crisis?

OPNT003 aims to provide a more effective treatment option for opioid overdoses, which are at historically high levels, driven largely by synthetic opioids like fentanyl.

When was the Fast Track Designation for OPNT003 announced?

The Fast Track Designation for OPNT003 was announced on November 4, 2021.