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Lyndra Therapeutics' Investigational Oral, Weekly Opioid Use Disorder Treatment LYN-014 Granted Fast Track Designation by FDA
28 July 2021 - - US-based clinical-stage biotechnology company Lyndra Therapeutics' LYN-014 oral, ultra-long-acting, extended-release levomethadone capsule in development for the weekly treatment of opioid use disorder, has received Fast Track designation from the US Food and Drug Administration, the company said.

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 10.1m Americans aged 12 or older reported misuse of opioids and an estimated 1.6 m had an OUD.

This month, the Centers for Disease Control and Prevention 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.

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.

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 m Americans aged 12 or older with a past-year OUD received medication-based treatment in the past year.

Lyndra received funding from the National Institute on Drug Abuse, part of the National Institutes of Health, through the Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative, to accelerate the development of this once-weekly levomethadone program.

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.

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.

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, which is defined as a problematic pattern of opioid use leading to clinically significant impairment or distress, affects approximately 1.6m people in the US 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.

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 m people aged 12 or older with a past-year OUD received medication-based treatment in the past year.

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.

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 and Melinda Gates Foundation and the NIH.

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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