04/01/2019 | Press release | Distributed by Public on 04/01/2019 06:21
SANTA MONICA, Calif., April 01, 2019 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. ('Opiant') (NASDAQ: OPNT), a specialty pharmaceutical company developing medicines for addictions and drug overdose, has been awarded the second tranche of $3.0 million from the total grant of approximately $7.4 million from the National Institutes of Health's ('NIH') National Institute on Drug Abuse ('NIDA') for the development of OPNT003, nasal nalmefene, a long-acting opioid antagonist for the treatment of opioid overdose.
Based on feedback from the U.S. Food and Drug Administration, Opiant intends to pursue a 505(b)(2) development path and anticipates the potential to submit a New Drug Application for the drug and intranasal delivery device combination in 2020.
'The award of this second tranche validates the progress we have achieved to date with OPNT003,' said Roger Crystal, M.D., Chief Executive Officer of Opiant. 'We will use these funds in 2019 to advance the program, including conducting a pivotal pharmacokinetic study. The development of stronger, longer-acting opioid overdose reversal products that potentially better address the next wave of potent synthetic opioids, like fentanyl, remains a critical area of focus for the NIH, and we are appreciative of their continued support.'
The NIH grant includes approximately $5.6 million to be funded through March 31, 2020, with the balance of the approximately $7.4 million to be funded in the period beginning April 1, 2020, subject to available government funds and continued progress of the development program.
The Company also announced that Phil Skolnick, Ph.D., D.Sc. (hon.), Opiant's Chief Scientific Officer, will participate in a symposium entitled, 'Addressing the Opioid Epidemic Through Science and Policy,' at the 2019 Experimental Biology meeting taking place April 6-9, 2019, in Orlando. Dr. Skolnick will give a talk entitled, 'Fighting Fire with Fire: Development of Intranasal Nalmefene to Treat Synthetic Opioid Overdose.' The symposium, hosted by the American Society of Pharmacology & Experimental Therapeutics, will take place on April 7 from 8-10 a.m., EST. Further details are available at https://www.aspet.org/aspet/meetings-awards/meetingsannual-meeting/aspet-annual-meeting-at-eb-2019/program/session-detail/addressing-the-opioid-epidemic-through-science-and-policy-39-19.
About Opiant Pharmaceuticals, Inc.
Opiant Pharmaceuticals, Inc. is a specialty pharmaceutical company developing medicines for addictions and drug overdose. NIDA, a division of the NIH, describes addictive disorders as chronic relapsing brain diseases which burden society at both the individual and community levels. Opiant's first drug overdose product, NARCAN® Nasal Spray, is was licensed to Adapt Pharmaceuticals, now owned by Emergent BioSolutions, Inc. For more information visit: www.opiant.com.
This press release contains forward-looking statements. 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, 2018 and Form 10-KT for the transition period August 1 to December 31, 2017, filed with the Securities and Exchange Commission on March 21, 2019 and March 7, 2018, respectively, 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.
For Investor Relations:Dan Ferry
LifeSci Advisors, LLC
For Media Inquiries:Julie Normart
Source: Opiant Pharmaceuticals, Inc.