Methadone

• “The change in the company name to DMK Pharmaceuticals Corporation and the new executive team are the first steps in this process.
• The DMK research study is designed to evaluate the efficacy of ZIMHI®, intramuscular naloxone, versus the standard of care generic version of NARCAN®, intranasal naloxone.
• Revenues for the third quarter ending September 30, 2023 were $0.0 million, compared to $1.5 million for the same period in 2022.
• Research and development (R&D) expense for the third quarter of 2023 was $0.4 million compared to $2.0 million in the third quarter of 2022.

• Digital health company CARI Health forms Advisory Board to support development of its wearable remote medication monitoring device .
• CARI Health intends to enable clinicians to view patient medication levels remotely in real time, ensuring correct dosages of prescribed medications.
• “We are honored to have these outstanding professionals on the CARI Health Advisory Board.
• CARI Health Advisory Board members include:
  Carla Marienfeld, MD, DFAPA, FASAM, board-certified, psychiatry, addiction psychiatry and addition medicine; Clinical Professor, UCSD
  Ken Stoller, MD, Professor of Clinical Psychiatry and Behavioral Sciences at Johns Hopkins University; Medical Director Behavioral Health for Johns Hopkins Health Plan
  “The promise of methadone patients being able to demonstrate compliance remotely, without daily clinic visits, is what attracted me to CARI Health,” said Patient Advocate Brenda Davis.

• Digital health startup CARI Health was awarded an SBIR Fast Track grant from the National Institute on Drug Abuse (NIDA), an agency of the National Institutes of Health (NIH), to help it bring the world’s first wearable medication monitor to market.
• CARI Health is eligible for up to $2.8M over three years as project milestones are successfully completed within Phase I and Phase II portions of the grant.
• The award funding will go toward supporting product development and conducting human clinical studies for CARI Health’s wearable remote medication monitoring device .
• The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

• The Netflix series Painkiller recently depicted how the over-prescribing of the medicine OxyContin wreaked havoc on American society.
• Today the grim reality is that opioid-related deaths in North America reached a record level in 2022, with more than 109,000 fatalities in the United States.
• The opioid overdose crisis has been ongoing for over two decades in Canada and the U.S.

The roots of the crisis

• After introduction of the opioid painkiller OxyContin in 1996, Purdue Pharma marketed the drug aggressively, underplaying its potential for addiction.
• To address addiction, prescription monitoring programs aimed to limit supply but many patients then sought illicit opioids, leading to large heroin markets in the 2010s.
• Fentanyl is extremely toxic — up to 100 times stronger than heroin — and is largely responsible for the increase in overdose deaths.

1. Treat substance use disorders as a public health problem

• In reality the data shows that illegal drug prices have fallen whilst purity and deaths have increased.
• Overdose deaths have also increased in prisons showing that places with even the highest level of security are vulnerable to drug smuggling.
• Focusing on the opioid crisis through a public-health approach includes massively increasing access to care and treatment for patients experiencing substance use disorder.

2. Find better treatments through research

• Although these are effective when used, there are barriers to access and long-term engagement with these treatments.
• We need more innovation to rapidly increase access to care and to find better therapies that suit the needs of different patients.
• These research initiatives aim to increase the number of evidence-based treatments that can be used to enhance patient recovery and quality of life.

3. Stop the international spread of the epidemic

• Currently the epidemic is contained within North America but there is the real concern of the crisis spreading to other countries.
• Clinicians must remain actively vigilant on how they prescribe these drugs.
• There should be greater international regulation in the marketing and operational strategies of pharmaceuticals, and oversight of the “revolving door” between industry and regulator employment.
• There is a potential conflict of interest when pharma companies hire the government employees who oversee their applications.