Since 2020, Awakn Life Sciences Corp. AWKNF reports that it has been researching, developing and commercializing therapeutics to treat addiction with a near-term focus on alcohol-use disorder (AUD).
The company is undeniably doing important work - addiction remains one of the most poorly-treated chronic medical diseases involving complex interactions among brain circuits, genetics, the environment and an individual’s life experiences.
Some addiction facts by the American Addiction Centers paint a disturbing picture of the situation:
- According to the National Survey on Drug Use and Health (NSDUH), 19.7 million American adults ages 12 and older battled a substance-use disorder in 2017.
- Almost 74% of adults suffering from a substance-use disorder in 2017 struggled with an alcohol-use disorder.
- About 38% of adults in 2017 battled an illicit drug-use disorder.
- That same year, 1 in 8 adults struggled with both alcohol- and drug-use disorders simultaneously.
- In 2017, 8.5 million American adults suffered from both a mental health disorder and a substance-use disorder, or co-occurring disorders.
- Drug abuse and addiction cost American society more than $740 billion annually in lost workplace productivity, healthcare expenses and crime-related expenses.
Addiction is one of the biggest unmet medical needs in America and the world with more than 400 million people globally suffering from AUD, and only 16% of those seeking treatment.
Even for those who pursue treatment, relapse rates remain consistently high, with 75% resuming dangerous levels of alcohol consumption within 12 months of treatment.
More worryingly, the COVID-19 pandemic seems to have exacerbated the issue. With most treatment centers and support groups shuttered during the pandemic’s peak, most addicts couldn’t get help.
Can Technology Help?
As the numbers continue to soar, experts believe effective and innovative technologies could offer hope to addicts as they may eliminate the need for in-person care and treatment. These technologies could hold the key to fighting addiction in the future.
That’s why companies like Awakn, Honeywell International Inc. HON, Abbott Laboratories ABT and SOBR Safe Inc. SOBR may have a key stake in the fight.
Awakn recently signed a drug development agreement with Catalent Inc. CTLT, a global leader in enabling biopharma, cell, gene and consumer health.
The agreement focuses on investigating a market-ready proprietary formulation and optimized delivery route for methylenedioxy-methamphetamine (MDMA) using Catalent’s proprietary Zydis® orally disintegrating tablet technology.
A statement announcing the partnership described Zydis as a unique, freeze-dried, oral solid dosage form that disperses almost instantly in the mouth — without the need for water — and with a dispersion speed of as little as three seconds.
Zydis claims the drug is the world’s fastest and best-in-class orally disintegrating tablet and has the potential to deliver a quicker onset of activity. Awakn plans to use Zydis technology in its late-stage MDMA-assisted therapy clinical trials.
The agreement will allow Awakn to conduct feasibility studies using Zydis technology for addiction, including substance and behavioral addictions, as well as other mental health disorders, including anxiety, depression, post-traumatic stress disorder and eating disorders.
The outcome of Awakn’s Phase IIa clinical trial, which examined MDMA-assisted therapy as a treatment for AUD, was positive.
The trial results, published in The Journal of Psychopharmacology in February 2021, demonstrated the potential for MDMA-assisted therapy as an effective treatment for AUD.
“Having the right partner to help facilitate our upcoming Phase IIb clinical trial is key, but it also provides a defined pathway towards regulatory approval, which is the goal of the program,” Awakn CEO Anthony Tennyson said. “With such a large cohort of people globally suffering with AUD and a current standard of care that lacks long-term efficacy, a new, more effective treatment has never been more needed.”
Tom Hawkeswood, Catalent’s president and division head of pharma product delivery, said the company has a track record of working with partners to develop, launch and supply new therapies that are differentiated from traditional and generic dose forms and difficult to emulate.
“Zydis technology provides multiple potential benefits, including initial acceptance, adherence, convenience and advantages for products where a rapid onset of action is possible,” he said.
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