Developing medical products and regimens that address addiction

• Founded with the intent to develop novel therapeutic products derived from psychedelics
• There is a body of research that leads to the conclusion that psychedelic-based medicines can offer new approaches to pain management as well as treatment for ailments such as addiction, anxiety and depression
• The company believes that using naturally sourced psychedelics in novel formulations holds the promise of delivering non-addictive solutions that are effective in managing pain and addiction.

Situation

Addiction to Opioids has become a global crisis.

• For many years, the pharmaceutical Industry has promoted the use of highly addictive pain medications to millions of patients.
• While these medications have been effective for pain relief, the highly addictive nature of the medications has created a problem with no practical  solution.
• The result has been millions of people becoming addicted to opioid medications, some who have turned to street versions of these drugs to manage their pain.
• The actions of these pharmaceutical companies have a devastating impact on families and communities.
• Current solutions proposing free or lower cost opioids is not a solution, society needs practical methods to break addiction, prevent relapse and replace addictive pain management therapies with non-addictive therapies.

Cost of Opioid Crisis in America

• The US Council of Economic Advisors estimate the cost to the US  economy at more than $500 billion annually, this equates to -almost 4% of GDP.
• In 2017, more that 70,000 Americans died of drug overdose, with around two-thirds of those deaths linked to opioids.
• The impact can be measured financially, with massive  health care and insurance costs as well as the significant costs of law enforcement.
• It has been estimated that it will require a large investment, as much as $100 billion, to fully address the crisis.

 The Company has identified two products for its first phase of development:

1. A one-per-day slow-release gel cap that assists the transition from opioids to non-addictive pain relief therapies by preventing relapse
2. A one-per-day slow-release gel cap that delivers non-addictive pain relief.

The Company has begun development efforts for these products, it is expected that these prototype products and formulations will be entering the next stage of the development process trials during this quarter

• As many of the formulations will be dealing with the treatment or management of opioid addiction or dependency, the company has prioritized the development of non-abusive delivery systems
• This will be an advance over conventional delivery systems such as tablets or inhalants that can be abused by overconsumption and overdosing

But wait, there’s more….

The Company Announced a Method for Producing MDMA that Reduces Manufacturing Time by Two Thirds

• Novel method of producing MDMA (3,4-methylenedioxy methamphetamine) that greatly reduces manufacturing time.
• Takes as little as 24 hours to complete, depending upon which method of reduction of the ketone to the secondary amine is being used.
• This is approximately one-third of the time that's required to complete current production methods using iso-safrole as an intermediate.
• Nirvana has filed an Application with the US Patent Office for this invention.
• MDMA is currently being studied and used for the treatment of a wide range of psychiatric disorders such as Post Traumatic Stress Disorder (PTSD), depression and anxiety to name a few.
• MDMA-assisted psychotherapy is currently in phase three clinical trials for the treatment of PTSD in the US, Canada, and Israel.
• This year the FDA expanded access to MDMA, allowing for its compassionate use in clinical settings by patients who have had no success with other FDA-approved treatment options.

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