Opioid Use Disorder Treatment

Background

The misuse of and addiction to opioids, which includes prescription pain relievers, synthetic opioids such as fentanyl and heroin, is a serious United States national public health crisis that affects both social and economic welfare. Recent estimates indicate that

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Americans

or about 4.2% of the total population, misuse opioids.

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The Centers for Disease Control and Prevention estimates that the “all-in” annual cost of opioid misuse in the United States is $78.5 billion, which includes the costs of healthcare, lost productivity, addiction treatment, and criminal justice involvement.

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of Individuals

using heroin (almost 900,000 individuals) first started using prescription opioids pain relievers.

There are some medications currently approved to treat Opioid Use Disorder (OUD), but given the scope and impact of this national public health crisis additional innovative solutions are needed.

Our Approach to Opioid Use Disorder Treatment

Opiant has two early-stage product candidates in our pipeline targeting OUD, a Heroin Vaccine (first-in-class) and an Opioid Antagonist Implant.

Heroin Background

Heroin is an opioid that is easily made from morphine, a widely used and very effective analgesic. About twice as potent as morphine, heroin is highly addictive. There are no approved medical uses for heroin in the United States. Beginning in 2010, the increasing availability of abuse-deterrent formulations of prescription opioids that cannot be readily injected or insufflated (snorted) resulted in a marked increase in the use of illicit heroin.

Further, according to the National Institute on Drug Abuse, Opioid Use Disorders are highly prevalent among criminal justice populations, with half of state and federal prisoners meeting the criteria for Substance Use Disorder. Because of reluctance to use available medicines to treat Opioid Use Disorder in criminal justice settings, the disease goes largely untreated during incarceration, and opioid use often resumes after release. Consequently, a former inmate’s risk of death within the first 2 weeks of release is more than 12 times that of other individuals, with the leading cause of death being a fatal overdose. Overdoses are more common when a person relapses to drug use after a period of abstinence due to loss of tolerance to the drug.

Heroin Vaccine OPNT005

Opiant in-licensed OPNT005, a novel heroin vaccine developed by the Walter Reed Army Institute of Research (WRAIR) in collaboration with the National Institute on Drug Abuse (NIDA), a division of the National Institute of Health (NIH). The heroin vaccine is designed to generate antibodies that bind to heroin injected into the bloodstream. The heroin bound to the antibody is too large to enter the brain, effectively keeping it out of the brain and potentially blocking both its pleasurable and harmful effects. Because the antibodies generated by this vaccine are highly specific to heroin and its metabolites, it can be used in conjunction with other medications approved to treat OUD, such as buprenorphine and methadone. Like other vaccines, the antibodies generated by an effective heroin vaccine aim to provide long-lasting “protection” against the effects of heroin.

Our Programs and Progress

The heroin vaccine candidate, currently in preclinical development, is fully-funded by a government grant through Phase 1/2a.  

  • Promising preclinical data generated with this vaccine
  • NIH awarded a grant to Walter Reed Army Institute of Research (WRAIR) and SUNY Upstate Medical University to advance the program through Phase 1/2a clinical trials
  • Pilot production of the vaccine is underway and will be followed by preliminary safety testing 

Long-Lasting Opioid Antagonist Implant OPNT006

OPNT006, under development, is an ultra long-acting implant containing an opioid antagonist. It would be surgically implanted beneath the skin (for example, above the biceps muscle or in the abdominal area) and slowly release the drug for up to 6 months.  Naltrexone, available as both a tablet and a monthly injection, is currently approved for treating OUD. By occupying opioid receptors in the brain, naltrexone and other opioid antagonists can block the reinforcing effects of opioids (that is, to produce a “high”). If this blockade can be sustained, the patient will “learn” that administering an opioid will not produce the desired reinforcing effect.

Because addiction is a chronic, relapsing disorder, the majority of patients beginning treatment with antagonist therapy do not remain in therapy.  However, the ability to make “one good decision” to receive an implant every six months may allow sufficient time for the patient to “unlearn” some of the behaviors associated with OUD while protecting the patient from an overdose if the patient misuses opioids.

Our Programs and Progress

The long-acting opioid antagonist implant is in preclinical development.