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Long-Acting Capsule Helps Reduce Opioid Use

Ambulance at night

(Ildar Sagdejev, Wikimedia Commons.

25 June 2021. A capsule designed to take once a week is shown in animal tests to continuously deliver a craving-reduction drug in that time and suppress opioid intake. The long-acting capsule is made by biotechnology company Lyndra Therapeutics in Watertown, Massachusetts that presented the findings this week at a virtual meeting of the College of Problems on Drug Dependence.

Opioid addiction continues to rise in the U.S., with the problem exacerbated by the Covid-19 pandemic. Data from Centers for Disease Control and Prevention show nearly 500,000 people died from drug overdoses between 1999 and 2019, with more than 70 percent of those deaths in 2019 involving an opioid. Provisional data from CDC show some 90,000 drug overdose deaths are expected for the 12 month period ending in November 2020, with the vast majority of those deaths traced to opioid drugs.

Lyndra Therapeutics designs long-acting drugs that evenly release their payloads from normal-sized capsules for one week or longer. The company’s extended-release therapies aim to improve medication adherence, a problem for many treatments that now require daily medications, such as opioid use disorder. Lyndra’s core technology is a star-shaped matrix with separate arms radiating out from the center, folded into the capsule. Once swallowed, the capsule dissolves and the matrix remains in the stomach for a week in most cases, with each arm containing the drug for release each day. After one week, the matrix degrades and safely passes through the intestines and out the body.

Buprenorphine remains in the blood stream

In their study, Lyndra’s researchers tested the company’s candidate therapy code-named LYN-013, one of two capsules designed by the company for opioid use disorder. LYN-013 delivers buprenorphine, a semi-synthetic opioid that satisfies the addiction cravings from opioids without creating the pleasurable intoxication. The drug is not easily formulated for oral use, and is usually given as a film that dissolves in the mouth. And it requires dosing in a doctor’s office or therapy site, with close monitoring, which reduces its utility for some patients. Abuse of buprenorphine is also a risk, thus its modest use and need for close scrutiny.

The study first assessed the chemical activity of LYN-013 in dogs, with tests of various doses of buprenorphine in the capsules. That part of the study shows LYN-013 releases a near-constant average buprenorphine dose of 24 milligrams a day. Those tests and later tests with monkeys show the drug-delivery matrix is retained in the stomach for seven days, with buprenorphine concentrations remaining in the blood stream for more than seven days. Tests with monkeys, initially non-dependent on opioids, show animals taking LYN-013 suppressed their consumption of the synthetic opioid fentanyl for seven days, with maximum suppression taking place within 48 hours.

“We are encouraged by the possibility of providing not just the first oral buprenorphine treatment, but to provide it as a weekly dosing option,” says Lyndra Therapeutics CEO Patricia Hurter in a company statement released through BusinessWire, “which has the potential to be a game-changer for the two million people in the U.S. with opioid use disorder that currently face a lack of therapeutic options, limited access to approved prescribers, and strict therapeutic regimes.”

Lyndra Therapeutics is spun off from the biomedical engineering and materials science labs of Giovanni Traverso and Robert Langer at MIT, co-founders of the company with venture investor Amy Schulman. The founders serve on the company’s board of directors.

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