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Lyndra Therapeutics accepts FDA-approved LYN-014 trial new drug application, which is oral levmethadone once a week for the treatment of opioid use disorder

Lyndra's LYN-014 opioid use disorder project is supported by the National Institute of Drug Abuse under the National Institutes of Health as part of a long-term initiative to help end addiction.

Taking levmethadone every week may change the management of opioid addiction among 2 million opioid use disorders in the United States.

Lyndra plans to start a phase 1 clinical trial in mid-2021.

May 6, 2021 at 08:30 AM EDT

Watertown, Mass. (Business News) - Lyndra Therapeutics, a clinical-stage biotechnology company dedicated to making daily pills a thing of the past, announced today that the US Food and Drug Administration (FDA) has approved LYN -014 Research New Drug (IND) application. The company's oral, ultra-long-acting, sustained-release levomethadone capsules are under development for the weekly treatment of opioid use disorders. Lyndra has received funding from the National Institute of Drug Abuse (NIDA) under the National Institutes of Health (NIH) to accelerate the development of this weekly L-Methylketone program through the NIH HEAL Initiative.

"To provide an opportunity for 2 million people in the United States who suffer from opioid use disorder to control their addiction through weekly rather than daily dosing. It is not only possible to improve compliance and therapeutic effects, but also to enable patients to Resume basic daily activities while managing their illness appropriately."—Tweet

LYN-014 aims to solve the severe unmet needs of patients with opioid use disorder, and provides a consistent level of targeted therapy of Levomethadone throughout the week through a single oral capsule once a week. The IND clearance rate enables Lyndra to initiate a phase 1 clinical trial in patients currently taking and controlling daily oral immediate release (IR) methadone. Levomethadone is the enantiomer of racemic methadone and has been approved for pain management and opioid maintenance treatment in Europe since the 1960s. Lyndra is planning to apply for fast-track certification for LYN-014. The company will work with the FDA to explore ways to speed up the entry of American patients in need.

"To provide an opportunity for the 2 million people in the United States who are struggling with opioid use disorders to control their addiction through weekly rather than daily dosing. It is not only possible to improve compliance and outcomes, but also to enable patients Resume basic daily activities while appropriately managing their illnesses," said Dr. Richard Scranton, Chief Medical Officer of Lyndra Therapeutics. "We thank the National Institutes of Health for their support in accelerating these efforts and look forward to this important clinical project is making progress."

About opioid use disorder

Opioid use disorder is a serious national crisis with a major public health impact. Approximately 2 million people in the United States are affected. This number is further exacerbated by the ongoing COVID-19 pandemic. 1 According to interim data from the Centers for Disease Control and Prevention, it is predicted that over 90, in the 12 months ending September 2020, there have been 20,000 drug overdose deaths in the United States, which is the highest number of drug overdose deaths in 12 months. The number of overdose deaths. 2 Although there are many evidence-based treatments for opioid use disorders, these drugs are highly regulated and may require patients to take their medications in specialized clinics daily while being observed by medical professionals. This rigorous treatment regimen poses a major challenge to ensure that patients receive, adhere to, and comply with these important treatments.

About Lyndra Therapeutics

Lyndra Therapeutics pioneered the first oral, ultra-long-acting, sustained-release therapy ever. This therapy has the potential to fundamentally change the way people take medicine, allowing patients to take pills once a week instead of once a day. The company's breakthrough sustained-release oral capsules are designed to provide drug concentrations for a full week or longer as long as one month, from a normal-sized capsule-an achievement that has never been achieved with oral treatment. Lyndra's powerful treatment pipeline is composed of therapies with established and well-known safety characteristics in many disease areas, where non-compliance is considered an important driver of results, including schizophrenia and other central nervous systems Systemic diseases, diabetes, cardiovascular diseases, and opioid use disorders, etc. The company is also committed to working with partners such as the Bill & Melinda Gates Foundation, through funding from the National Institutes of Health (NIH), in new chemical entities and various important global and public Advance its platform among health opportunities. For more information, please visit the company's website www.lyndra.com

The research reported in this announcement is supported by the National Institute of Drug Abuse through the NIH HEAL initiative, and the award number is UG3DA050310. The content is solely the responsibility of the author and does not represent the official views of the National Institutes of Health.


1. Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Management Center, US Department of Health and Human Services, RTI International. 2016 National Drug Use and Health Survey Results: Detailed table. Online: https://www.samhsa.gov/data/sites/default/files/NSDUH-DetTabs-2016/NSDUH-DetTabs-2016.htm. 2017

2. Center for Disease Control and Prevention. Count of deaths from temporary drug overdose.https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm. Access date: May 3, 2021.

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