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Lyndra Therapeutics’ Investigational Oral, Weekly Opioid Use Disorder Treatment LYN-014 Granted Fast Track Designation by FDA

WATERTOWN, Mass.–()–Lyndra Therapeutics, a clinical-stage biotechnology company working to make daily pills a thing of the past, today announced that LYN-014, the company’s oral, ultra-long-acting, extended-release levomethadone capsule in development for the weekly treatment of opioid use disorder (OUD), has received Fast Track designation (FTD) from the U.S. Food and Drug Administration (FDA).

“LYN-014 is an oral, weekly capsule of levomethadone – a medication not yet available in the United States – which has the potential to transform the experience of people living with opioid use disorder,” said Dr. Richard Scranton, Chief Medical Officer of Lyndra Therapeutics. “A weekly dosage form would free people from daily trips to methadone clinics and support consistency of treatment, recovery and wellbeing. There is a great need for new and improved, patient friendly treatments for OUD, as deaths from opioid misuse, already high, have surged during the COVID pandemic. The FDA’s decision to grant LYN-014 Fast Track designation speaks to their commitment to provide people living with OUD with new, innovative treatment options.”

Fast Track is designed to facilitate the development and expedite the review of drugs to treat serious conditions and address an unmet medical need. LYN-014, which was granted investigational new drug status in April, is set to begin a Phase 1 clinical trial this quarter.

According to 2019 CDC data, an estimated 10.1 million Americans aged 12 or older reported misuse of opioids and an estimated 1.6 million had an OUD.1 This month, the Centers for Disease Control and Prevention (CDC) reported that there were more than 93,000 drug-involved overdose deaths in 2020, according to provisional data, with more than 75% involving an opioid.2 This is up from an estimated 38,300 overdose deaths in 2010.3 Overdose deaths are just the tip of the iceberg, with many more nonfatal overdoses for every fatal overdose death.4

“The opioid epidemic is a significant public health crisis that is having a devastating effect on millions of Americans, their families and their communities,” said Sandra Comer1, PhD, Professor of Neurobiology in Psychiatry at Columbia University Vagelos College of Physicians and Surgeons, who will be an investigator for the trial. “Many of the treatments and interventions in our armamentarium were developed before the widespread availability of highly potent, illicit fentanyl, so it is vital that we develop new treatments and approaches for people struggling with opioid use disorder.”

While there are a number of evidence-based treatments available for OUD, most people who could benefit from medication-based treatment do not receive it. Approximately 7% of physicians are trained to effectively treat OUD5 and only an estimated 18% of the 1.6 million Americans aged 12 or older with a past-year OUD received medication-based treatment in the past year.6 Lyndra received funding from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), through the Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative, to accelerate the development of this once-weekly levomethadone program.

About LYN-014

LYN-014, Lyndra’s investigational oral, ultra-long-acting extended-release weekly levomethadone capsule, is being developed for the treatment of people living with opioid use disorder (OUD). The capsule is expected to achieve this through a novel design that will provide extended gastric residence, controlled, steady drug release and timely passage into the gastrointestinal tract. Levomethadone is an enantiomer of racemic methadone approved for use as a daily treatment in Europe for pain management and opioid maintenance therapy. Levomethadone has never been approved in the United States. LYN-014 was granted Investigational New Drug status by the FDA in April 2021. Treatment recommendations for OUD support the ongoing use of pharmacotherapy to reduce the risk of relapse7; LYN-014, an oral, once-weekly formulation, may provide a more sustainable regimen for patients who struggle with daily visits to a methadone clinic on a long-term basis.

About Opioid Use Disorder

Opioid overuse or misuse and the epidemic of overdose deaths related to opioids is a nationwide public health crisis with devastating consequences to individuals, families and communities. Opioid use disorder (OUD), which is defined as a problematic pattern of opioid use leading to clinically significant impairment or distress, affects approximately 1.6 million people in the U.S. Overdose deaths involving opioids claimed 500,000 lives from 1999-2019,8 and these numbers have risen further during the ongoing COVID-19 pandemic. The Centers for Disease Control and Prevention reports that drug-involved overdoses are a leading cause of injury-related death in the United States, leading to more than 93,000 deaths in 2020, according to provisional data, with more than 75% of these involving an opioid.9 While there are a number of evidence-based treatments available for OUD, most people who could benefit from medication-based treatment do not receive it. In 2019, only an estimated 18% of the 1.6 million people aged 12 or older with a past-year OUD received medication-based treatment in the past year.10 OUD is highly stigmatized, most healthcare professionals are not trained in treating OUD, and stringent laws and regulatory processes restrict access to approved treatments. Oral, once-weekly therapies have the potential to make medication for OUD more widely available to those who could benefit from treatment.

About Lyndra Therapeutics

Lyndra Therapeutics is pioneering the first-ever oral, ultra-long-acting, extended-release therapies, which have the potential to fundamentally change the way people take medicine by enabling patients to take a pill once a week rather than daily. The company’s breakthrough extended-release oral capsule is designed to provide consistent drug levels for an entire week or as long as a month, from one, normal-sized capsule – something no oral therapy has ever achieved before. Lyndra’s robust pipeline is made up of therapies with established and well-known safety profiles across a number of disease areas in which non-adherence is known to be a significant driver of outcomes, including schizophrenia and other central nervous system diseases, oral contraception and opioid use disorder, among others. The company is also committed to advancing its platform across new chemical entities and a variety of critical global and public health opportunities alongside partners such as the Bill & Melinda Gates Foundation and the NIH. For more information, visit the company’s website at www.lyndra.com.

Research reported in this announcement was supported by the National Institute on Drug Abuse through the NIH HEAL Initiative under Award Number UG3DA050310. The content is solely the responsibility of the authors and does not represent the official views of the National Institutes of Health.

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* Dr. Comer is receiving research support from the company as a subcontractor for this study through an NIH HEAL (Helping End Addiction Long-term) grant.

1 Substance Abuse and Mental Health Services Administration. (2020). Key substance use and mental health indicators in the United States: Results from the 2019 National Survey on Drug Use and Health (HHS Publication No. PEP20-07-01-001, NSDUH Series H-55). Rockville, MD: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration. Retrieved from https://www.samhsa.gov/data/

2 Ahmad FB, Rossen LM, Sutton P. Provisional drug overdose death counts. National Center for Health Statistics. 2021.

3 Centers for Disease Control and Prevention, National Center for Health Statistics, Multiple Cause of Death 1999-2019 on CDC WONDER Online Database, released 12/2020.

4 Centers for Disease Control and Prevention, National Center for Injury Prevention and Control. https://www.cdc.gov/drugoverdose/nonfatal/index.html

5 Substance Abuse and Mental Health Services Administration website. Medication Assisted Treatment, Practitioner and Program Data. Updated Feb. 22, 2021. Accessed July 23, 2021. https://www.samhsa.gov/medication-assisted-treatment/practitioner-resources/DATA-program-data

6 Han B. Key substance use and mental health indicators in the United States: Results from the 2019 National Survey on Drug Use and Health (HHS Publication No. PEP20-07-01-001, NSDUH Series H-55). Rockville, MD: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration. 2020.

7 Coffa D, Snyder H. Opioid Use Disorder: Medical Treatment Options. Am Fam Physician. 2019 Oct 1;100(7):416-425. PMID: 31573166.

8 Centers for Disease Control and Prevention website. Understanding the Epidemic. Updated March 27, 2021. Accessed July 23, 2021. https://www.cdc.gov/opioids/basics/epidemic.html

9 Centers for Disease Control and Prevention website. Opioids. Updated June 17, 2021. Accessed July 23, 2021. https://www.cdc.gov/opioids/index.html

10 Han B. Key substance use and mental health indicators in the United States: Results from the 2019 National Survey on Drug Use and Health (HHS Publication No. PEP20-07-01-001, NSDUH Series H-55). Rockville, MD: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration. 2020.

 

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