River Stone Biotech’s priority focus is on supplying life-changing for use in important substance use, overdose and pain treatment programs around the world. With high prevalence and a need to effectively treat these conditions, we expect a rising demand for the production of these important APIs.

Opioid Use Disorder

Over 16 million people suffer from opioid use disorder (OUD) worldwide 1. Despite the existence of effective medications for OUD, treatment rates remain low, with only 18% of 1.6 million eligible US patients receiving medication-assisted treatment for OUD in 2022 2. The need for treatment is expected to increase in light of the ongoing opioid epidemic. The growing demand has put the buprenorphine market on a projected CAGR of 10.8% until 2028 3. Buprenorphine (as monotherapy or in combination with Naloxone) and Naltrexone are two medications approved for the treatment of opioid use disorder.

Based on…

  • The need for increasing access to OUD medications.
  • The high cost and complex production of APIs used in OUD medications.
  • The environmental burden of APIs used in OUD medications.

River Stone Biotech has recognized an opportunity for more efficient and environmentally conscientious provision of Buprenorphine, Naloxone and Naltrexone for treating OUD.

Opioid Overdose

Opioid overdose remains a crisis of epidemic proportion in the United States. Deaths from opioid overdose have risen over 750% since 1999, culminating in over 80,000 opioid overdose deaths in 2021 4.

River Stone Biotech has recognized a need for an increased provision of more Naloxone API that utilizes a more efficient and environmentally conscientious production process.

Following the upsurge in the prevalence of fentanyl and its analogues, the potential of Nalmefene for treating opioid overdose is being investigated. Nalmefene is a longer-acting opioid antagonist that may be more effective in reversing overdose caused by synthetic opioids. River Stone Biotech is exploring how its platform could be leveraged to reinvent the production of Nalmefene API.

 

River Stone Biotech

Alcohol Use Disorder

14.5 million people suffered from AUD in the US in 2019. Deaths involving alcohol increased from 78,927 in 2019 to 99,017 in 2020, and alcohol was listed in 1 in 6 drug overdose deaths in 2019 & 20205. The largest rises have been seen in people aged 25-34 and 35-44, also the people most at risk of OUD.

During the Covid-19 pandemic, the prevalence of major depressive disorder and generalized anxiety disorder increased 28% and 26% respectively, providing a perfect storm to enable alcohol use that will continue to threaten lives, livelihoods and relationships.

Still, less than 10% of people with AUD receive any treatment, despite 3 FDA approved medications – including Naltrexone 5.

River Stone Biotech expects demand for Naltrexone as treatment for AUD to increase. Accordingly, we recognize a need for increased provision of reduced-cost Naltrexone API that utilizes a more efficient and environmentally conscientious production process.

River Stone Biotech is also exploring how its platform could be leveraged to reinvent the production of Nalmefene, used to treat alcohol dependence.

Pain

Chronic pain affects over 30% of people worldwide, with rates expected to increase in line with an aging global population 6.

Buprenorphine is an effective medication used to treat both acute and chronic pain.

River Stone Biotech has recognized the need for a more efficient and environmentally conscientious provision of Buprenorphine API for use in pain treatment.

River Stone Biotech also produces Naloxone API, frequently used in combination with Oxycodone for the treatment of chronic pain.

Our Solution

River Stone Biotech has developed a proprietary method of producing the APIs Buprenorphine, Naltrexone and Naloxone more efficiently. These APIs cover indications including: opioid use disorder, opioid overdose, alcohol use disorder and pain.

  • Our vision is that our approach will support future demand for these molecules as the high prevalence of pain, substance use disorders and overdose persists.
  • Our platform may also be utilized to produce other APIs for use in the same indications or for other therapeutic purposes.
  • Our supply of quality, environmentally improved, reduced cost APIs will help enable the provision of crucial treatments.

References
1. Dydyk, A.M., Jain, N.K. and Gupta, M., 2021. Opioid use disorder. In StatPearls [Online]. StatPearls Publishing.
2. Volkow, N., 2022, ‘Research on Drug Abuse and Addiction: Progress, Opportunities and Challenges’, CPDD 2022: Minneapolis, MN, 11-15 June 2022
3. Fortune Business Insights. 2021. Opioid Use Disorder Market Forecast 2021-2028 | Opioid Use Disorder Industry Size, Share, Growth & Forecast. India. Fortune Business Insights
4. Ahmad FB, Cisewski JA, Rossen LM, Sutton P. Provisional drug overdose death counts. National Center for Health Statistics. 2022.Designed by LM Rossen, A Lipphardt, FB Ahmad, JM Keralis, and Y Chong: National Center for Health Statistics.
5. Koob, G., 2022, ‘NIAAA Update: Closing the Treatment Gap’, CPDD 2022: Minneapolis, MN, 11-15 June 2022
6. The Lancet., 2021. The Lancet Chronic Pain Series [Online]. Available from: https://www.thelancet.com/series/chronic-pain. [Accessed 08/22/22].