NIDA’s Office of Translational Initiatives and Program Innovations (OTIPI) supports developing and commercializing novel technologies and products to prevent, diagnose, and treat substance use disorders. The following companies have received NIDA funding through the Small Business Innovation Research and Small Business Technology Transfer programs.
Achieve Life Sciences, Inc.
Achieve Life Sciences is a late-stage pharmaceutical company supporting the development and commercialization of cytisinicline, a potential treatment for smoking cessation and nicotine dependence.
A clinical trial supported by Achieve Life Sciences and NIDA on cytisinicline suggests that the treatment is safe and effective. Of the 160 participants who used nicotine e-cigarettes, those treated with cytisinicline were 2.6 times more likely to have quit vaping compared to those who received a placebo drug. Results were published in JAMA Internal Medicine in May 2024.
In July 2024, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for cytisinicline for nicotine e-cigarette, or vaping, cessation. This designation aims to speed up the development and review process for promising drugs that are intended to treat serious conditions when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies. There are currently no FDA-approved treatments specifically indicated for vaping cessation.
NIDA Funded Project
Boulder Care, Inc.
Boulder Care is a digital clinic offering long-term support and treatment for substance use disorders. There are evidence-based treatments for opioid use disorder, but many people who need treatment face geographical and other challenges accessing it. With NIDA support, Boulder Care is testing telehealth applications so people can receive care remotely.
In May 2024 Boulder Care raised an additional $35 million in funding. The online publication Fierce Pharma named the company one of its Fierce 50 Honorees of 2024, which highlight “people and companies who are driving meaningful change in healthcare, pharma, and biotech.”
NIDA Funded Projects
- Evaluating the Usability, Efficacy and Commercial Utility of a Digital Platform to Deliver Comprehensive Treatment for Opioid Use Disorder
- Right Tools, Right Time, Right Place: Telehealth for Opioid Use Disorder in Vulnerable Settings
Spark Biomedical, Inc.
With support from NIDA, Spark Biomedical developed a wearable neurostimulation device to treat the symptoms of opioid withdrawal and improve retention in addiction treatment. The company is also developing a neurostimulation device to support the treatment of infants with neonatal opioid withdrawal syndrome.
In August 2024, Spark Biomedical’s Sparrow® Ascent, the first FDA-cleared non-invasive neurostimulation device for opioid withdrawal treatment that delivers transcutaneous auricular neurostimulation (tAN ®) therapy, and its daily-disposable Earpiece Kit were issued two unique Healthcare Common Procedure Coding System (HCPCS) codes by the Centers for Medicare and Medicaid Services (CMS). The codes are a critical step in securing insurance coverage. The device is the first opioid withdrawal treatment to be recognized as durable medical equipment.
NIDA Funded Projects
- Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Treatment for Neonatal Opioid Withdrawal Syndrome
- Development of a Machine Learning Algorithm to Detect Opioid Withdrawal and Cravings to Increase Treatment Retention
- Delivering Transcutaneous Auricular Neurostimulation to Improve Treatment Retention in Opioid Use Disorder
Axcend Corporation
Axcend® provides high-performance liquid chromatography (HPLC) systems, a common tool used in laboratories to identify and quantify components in a mixture. HPLC systems are used in drug testing facilities to identify drugs in human specimens. With support from NIDA, Axcend® is developing improved methods for using its compact, portable HPLC systems to support routine point-of-care drug screening in drug treatment centers.
NIDA Funded Project
Instanosis Inc.
Instanosis is a start-up diagnostic company dedicated to advancing rapid and portable diagnostic solutions for a variety of diseases and conditions.
In April 2024, the FDA approved the company’s InstaStrip-Fentanyl Rapid Test, a dipstick test to detect fentanyl in human urine. Developed with support from NIDA, the instrument-free, high-sensitivity test is available over the counter or by prescription.
NIDA Funded Projects
- Rapid, Instrument-free and High Sensitivity Over-the-counter Urine Fentanyl Testing
- Addressing Emerging Drug Threats with InstaStrip Rapid Tests
- A Lateral Flow Assay for Rapid Saliva Fentanyl Detection (sFENTANYL)
Prapela, Inc.
Prapela is a startup developing non-pharmacological solutions for newborns with serious medical conditions. Its noninvasive stimulation therapy, which was developed and tested with NIDA support, is delivered via a pad used in infant incubators and bassinets in the hospital setting. It improves breathing and lung performance in newborns.
The FDA granted Breakthrough Device designation to Prapela in January 2023 as a potential treatment for apnea of prematurity, which is when premature newborns have difficulty breathing, and in October 2019 as a potential treatment for neonatal opioid withdrawal syndrome.
In January 2023, the European Patent Office granted a patent on Prapela's technology for reducing irritability in babies with colic and opioid exposure.
NIDA Funded Projects
- Prapela™ SVS: A cost-effective stochastic vibrotactile stimulation device to improve the clinical course of infants with neonatal abstinence syndrome
- Prapela® SVS incubator pad: A cost-effective stochastic vibrotactile device to improve the clinical course of infants with apnea of prematurity
More Information
Find out more about NIDA’s Small Business Programs and information on its funding opportunities.