About Opiant Pharmaceuticals

Opiant Pharmaceuticals, Inc., a specialty pharmaceutical company, engages in developing medicines for addictions and drug overdose. Principal Products or Services and Markets OPNT003 - Nasal Nalmefene for Opioid Overdose Reversal (OOR) Development Program for OPNT003 The company is pursuing a 505(b)(2) development path for OPNT003, with the potential to submit the New Drug Application (NDA) with the Food and Drug Administration (FDA) for the drug and intranasal delivery device combination in the first half of 2022. Nalmefene for injection was previously approved by the FDA for treating suspected or confirmed opioid overdose. The 505(b)(2) pathway allows companies to rely in part on the FDA’s findings of safety and efficacy for a previously approved product and to supplement these findings with a limited set of their own studies to satisfy FDA requirements, as opposed to conducting the full array of preclinical and clinical studies that would typically be required. The company has reached agreement with the FDA to perform a pharmacodynamic (PD) study in healthy volunteers to support the company’s OPNT003 NDA application. In February 2021, the first patients were dosed in a confirmatory pharmacokinetic (PK) study for OPNT003, nasal nalmefene, for the treatment of opioid overdose. In July 2021, the company announced positive top-line results from the study. In April 2021, the first subjects were dosed in a head-to-head clinical pharmacodynamic (PD) study comparing the effectiveness of OPNT003, nasal nalmefene, with nasal naloxone. In November 2021, the company received Fast Track Designation from the FDA for OPNT003, nasal nalmefene. Fast Track is an FDA process designed to facilitate the development and expedite review of potential therapies that seek to treat serious conditions and fill an unmet medical need. This designation enables early and frequent communication with the FDA, in addition to the potential for a rolling submission of an NDA application. In February 2022, the company announced positive top line results from a multi-dose PK study for OPNT003, nasal nalmefene, for the treatment of opioid overdose. The crossover design study was conducted in 23 healthy subjects comparing the pharmacokinetic (PK) profile, safety, and tolerability of OPNT003 when given as a single 3mg dose in one nostril, as a single dose in each nostril, and as two doses in one nostril. The company has full commercial rights to OPNT003, and it was awarded a grant from the National Institute of Health (NIH). The grant provides the company with additional resources for the ongoing development of OPNT003. In 2014, the company entered into a license agreement with Adapt Pharma Operations Limited (Adapt), which subsequently became a wholly owned subsidiary of Emergent BioSolutions, Inc. (EBS) (the ‘Adapt Agreement’). In March 2019, the company entered into Amendment No. 2 to the Adapt Agreement (Amendment No. 2) where certain modifications were made to the Adapt Agreement. OPNT002 - Nasal Naltrexone for Alcohol Use Disorder (AUD) The company is developing OPNT002, nasal naltrexone for AUD. It has generated encouraging Phase 1 clinical data demonstrating rapid nasal absorption of OPNT002, which supports its suitability for use on an as needed basis, as high levels of naltrexone can be delivered within minutes, which is likely to be very important during a period of craving. The company has also received feedback from the FDA on its proposed 505(b)(2) development plan, which accepts a harm reduction-based primary endpoint rather than a primary endpoint based on abstinence. In October 2019, the company completed a dose ranging study, confirming the suitability of its OPNT002 formulation of AUD. During January 2022, the company dosed the first patient in this Phase 2 clinical trial. The trial will determine whether OPNT002 reduces heavy drinking as measured by a change in the World Health Organization (WHO) drinking risk levels. The trial features a Sequential Parallel Comparison Study Design aiming to reduce placebo response. Results from the trial are expected in 2023. OPNT004 - Drinabant Injection for Acute Cannabinoid Overdose (ACO) In December 2018, the company entered into an exclusive global licensing agreement with Sanofi for the development and commercialization of drinabant for the treatment of acute cannabinoid overdose (ACO). It intends to develop drinabant, a selective, high affinity cannabinoid CB-1 receptor antagonist, as an injectable for administration in an emergency department setting. In a proof of principle study that Sanofi completed with 36 patients, oral drinabant blocked both subjective and objective psychological effects of inhaled delta9-tetrahydrocannabinol (THC). Sanofi also generated extensive safety data in Phase 1 and 2 studies with more than 700 subject for up to 24 weeks. In January 2020, the company signed a Letter of Intent with the National Center for Advancing Translational Sciences (NCATS) to collaborate on the development of OPNT004. This collaboration, carried out under a Cooperative Research and Development Agreement provides development research for certain pre-clinical activities and studies to support the company’s planned filing of an Investigational New Drug (IND) application for OPNT004. Activities carried out under this agreement have resulted in the development of formulations, which may be suitable for parental administration of OPNT004. These formulations are being tested for stability, with pre-clinical toxicology studies scheduled in 2022. Opioid Use Disorder In October 2016, the company in-licensed OPNT005, a heroin vaccine from Walter Reed Army Institute of Research (WRAIR). This is an early stage pre-clinical asset and requires further pre-clinical research before human testing. In October 2018, researchers at the U.S. Military HIV Research Program at the WRAIR and SUNY Upstate Medical University in Syracuse, New York, were awarded a grant by NIH to advance OPNT005, through Phase 1/2a clinical trials to assess its safety and efficacy. Other Activities In November 2016, Opiant Pharmaceuticals UK Limited (OPUK) was incorporated under the Companies Act of 2006 as a private company. OPUK is a wholly-owned subsidiary of the company. In 2017, the company entered into a license agreement (the ‘License Agreement’) and a related supply agreement (the ‘Supply Agreement’) with Aegis Therapeutics LLC, acquired by Neurelis, Inc. in 2018, the combined entity, ‘Neurelis’, pursuant to which the company was granted an exclusive license (the ‘License’) to Neurelis’ proprietary chemically synthesizable delivery enhancement and stabilization agents, including but not limited to, Neurelis’ Intravail absorption enhancement agents, ProTek and HydroGel (collectively, the ‘Technology’) to exploit the Compounds (as such are defined in the License Agreement); and a product containing a Compound and formulated using the Technology (Product), in each case for any and all purposes. The License Agreement restricts the company’s ability to manufacture any Aegis Therapeutics LLC (Aegis) excipients included in the Technology (Excipients), except for certain instances of supply failure, supply shortage or termination of the Supply Agreement, and the company shall obtain all supply of such Excipients from Neurelis, Inc. (Neurelis) under the Supply Agreement. The License Agreement also restricts Neurelis’s ability to compete with the company worldwide with respect to the Exploitation (as defined in the License Agreement) of any therapeutic, including a Compound or derivative or active metabolite of a Compound without the company’s prior written consent. The effective date of the License Agreement and the Supply Agreement is January 1, 2017. In 2018, the company entered into a development and manufacturing agreement for OPNT003 nasal nalmefene, a potent, long-acting opioid antagonist for the treatment of opioid overdose with Consort Medical plc (Consort), a contract development and manufacturing organization. Under this agreement, Aesica and Bespak, wholly-owned subsidiaries of Consort, will work with the company to produce a pre-filled delivery nasal spray with nalmefene. As part of the agreement, Aesica Queenborough Limited (Aesica) will supply the company with clinical samples and registration batches for the purposes of performing clinical studies and obtaining regulatory approvals. Further, upon approval by the FDA, Aesica and Bespak will manufacture and supply the commercial device for the company. In 2020, the company notified Aesica that, effective immediately, it was terminating the Agreement pursuant to Section 18.2(a) of the Agreement. In July 2020, the company entered into a Project Scope Agreement (PSA) pursuant to a Master Services Agreement (MSA) with Summit Biosciences, Inc. (Summit), to support the development and manufacture of a nasal spray device for opioid overdose, with the ability to expand to additional programs in the future. In accordance with the PSA, Summit will develop and produce certain pre-filled nasal spray products using a device previously evaluated as part of other FDA-approved nasal spray products. In October 2020, the company entered into a Master Services Agreement (MSA) with AptarGroup, Inc. (Aptar) to provide non-exclusive technology access and co-development services for the development and submission of an opioid antagonist for the treatment of opioid overdose using Aptar’s nasal Unidose device (the ‘UDS Device’). Patents The company has obtained and intends to seek to obtain, when appropriate, protection for its products and proprietary technology by means of the United States and foreign patents, trademarks and contractual arrangements. It has issued the United States patents and pending United States patent applications, as well as pending foreign patent applications or issued foreign patents, relating to its marketed products and product candidates. The company also has the United States and foreign patent applications pending relating to novel product concepts. Research and Development During the year ended December 31, 2021, the company incurred research and development expenses of $16.8 million. Competition Amphastar Pharmaceuticals, Inc. competes with NARCAN with their naloxone injection. Kaleo competes with NARCAN with their auto-injector known as EVZIO (naloxone HCl injection) Auto-Injector. History The company was founded in 2005. It was incorporated in the state of Nevada in 2005. The company was formerly known as Madrona Ventures, Inc. and changed its name to Lightlake Therapeutics Inc. in 2009. Further, the company changed its name to Opiant Pharmaceuticals, Inc. in 2016.