naltrexone intranasal (OPNT002 nasal spray) / Indivior - LARVOL DELTA

Opiant Pharmaceuticals Reports Third Quarter 2019 Financial Results and Provides Corporate Update (GlobeNewswire, Opiant Pharmaceuticals, Inc.) - "Earned a one-time $13.5 million milestone payment based on net sales of NARCAN® exceeding $200 million through the quarter ended September 30, 2019. Continued preparations to conduct confirmatory pharmacokinetic (PK) study of nasal nalmefene, OPNT003, for the treatment of opioid overdose....expects to report top-line data from the PK study in the first quarter of next year, but continues to anticipate filing a New Drug Application for OPNT003 in the fourth quarter of 2020. Dose selection study for OPNT002 for Alcohol Use Disorder is nearing completion....expects to complete the subsequent Phase 2 study during the second half of 2020....$1.3 million for payments made to buyout the net profit interests in Nasal Nalmefene held by investors...For the nine months ended September 30, 2019, Opiant recognized approximately $30.4 million of revenue from the license agreement between it and Adapt for the sale of NARCAN® Nasal Spray..."

Commercial • NDA • New trial • PK/PD data • Sales • Trial completion • Trial status

Opiant Pharmaceuticals to host a research & development meeting on emerging therapeutics for the treatment of addiction and drug overdose (GlobeNewswire) - Opiant Pharmaceuticals, Inc....announced today that Chief Executive Officer, Roger Crystal...will provide an in-depth review of Opiant's most advanced programs for treating addiction and drug overdose, on Thursday, October 17th in New York City at 12:00 pm ET. Three presentations will describe the development of: OPNT 003: Nalmefene nasal spray for the treatment of Opioid Overdose; OPNT 002: Naltrexone nasal spray for the treatment of Alcohol Use Disorder."

Live event

Opiant Pharmaceuticals Reports Second Quarter 2019 Financial Results and Provides Corporate Update (GlobeNewswire, Opiant Pharmaceuticals, Inc.) - “We expect our balance sheet will be further strengthened in the next approximately six months, based on the timing of the one-time milestone payment of $13.5 million due to Opiant from Emergent BioSolutions (EBS) when net sales of NARCAN® exceed $200 million in the 2019 calendar year.'...The $3.0 million increase in royalty revenue was attributable to a significant increase in sales of NARCAN® Nasal Spray to approximately $73 million for the second quarter of 2019...For the six months ended June 30, 2019, Opiant recognized approximately $9.9 million of revenue from the license agreement between it and Adapt for the sale of NARCAN® Nasal Spray...Initiated OPNT002 formulation selection study in Alcohol Use Disorder and began preparations for a Phase 2 study; expect to begin enrolling patients in this study later this year."

Clinical • Commercial • New trial

Opiant Pharmaceuticals Reports First Quarter 2019 Financial Results and Provides Corporate Update (GlobeNewswire, Opiant Pharmaceuticals, Inc.) - "'With a plasma half-life essentially identical to naloxone, OPNT002 is well-suited for 'on-demand' dosing to treat AUD...We anticipate the completion of the Phase 2 trial in the second half of 2020.'...For the three months ended March 31, 2019, Opiant recognized approximately $3.7 million of revenue from the license agreement...for the sale of NARCAN® Nasal Spray...The $2.1 million increase in royalty revenue was attributable to a significant increase in sales of NARCAN® Nasal Spray to approximately $65.5 million...should Net Sales of NARCAN® exceed $200 million in the 2019 calendar year."

Commercial • Sales • Trial completion

Opiant Pharmaceuticals Announces Publication of Clinical Pharmacokinetic Data Supporting Potential of OPNT002, Nasal Naltrexone, for Treatment of Alcohol Use Disorder (GlobeNewswire, Opiant Pharmaceuticals, Inc.) - "Opiant Pharmaceuticals, Inc....today announced that clinical pharmacokinetic data of OPNT002, nasal naltrexone containing Intravail® (dodecyl maltoside), were published online in The Journal of Clinical Pharmacology. 'One of the most interesting findings of this clinical study was that the plasma half-life of OPNT002 is essentially identical to the overdose reversal agent naloxone,' said Phil Skolnick, Ph.D., D.Sc. 'This was unexpected given the longer half-life of oral naltrexone and may limit the usefulness of OPNT002 as a rescue medication'...'The results and insights from this study have formed the basis for an OPNT002 formulation selection study in AUD, which is slated to begin in the second quarter of 2019 followed by enrollment of patients in a Phase 2 study later this year...'"

Enrollment open • New trial • PK/PD data