With overdoses soaring in the U.S., more tools are needed in the toolbox to help people with drug and alcohol addiction. Narcon, an overdose-reversal drug used by paramedics and hospitals for decades, was recently approved for over-the-counter sale.

A new drug that helps people with a substance dependency detoxification—in five days—from opioids and alcohol without painful withdrawal symptoms recently completed a proof-of-concept clinical trial. Wendy Komac is bringing it to market. She has dealt with substance abuse, has been sober for nearly 40 years, and is an advocate for others fighting addiction.

Komac’s company, Bryleos, has completed the research and raised $5 million to bring the drug treatment to market.

In the U.S., nearly 20 million people battle a substance disorder. Almost three-quarters of adults with a substance dependency struggle with alcohol use disorder and about 38% battle illicit drug use disorder.

Detoxing from substance misuse is a challenging yet essential step for those in recovery. Depending on the type and severity of addiction, detox can take a few days to several weeks. Physical, psychological, and cognitive symptoms often accompany it. These include sweating, nausea, vomiting, diarrhea, muscle cramps, and headaches on the physical side; anxiety, depression, irritability, and mood swings on the psychological side; and difficulty concentrating or making decisions on the cognitive side.

Komac understands firsthand what a difficult journey it is. “I was an addict and alcoholic at the age of 15,” sighed Komac. ”Most days, I drank about two bottles of vodka with a little cocaine chaser to keep me awake.”

Twelve years later, in 1986, when Komac sobered up, the general practice for recovery was being anonymous. Addiction was viewed with stigma and discrimination, making it difficult for addicts to seek help. Treatment options were limited, resulting in a fear of relapsing. All these factors contributed to the general practice of keeping one's addiction anonymous—out of shame, guilt, and a fear of judgment. However, times have changed, and more options for treatment and support are available to those struggling with addiction.

Komac didn’t want anonymity. “There's nothing worse than being as optionless and hopeless as I was for over a decade,’ groaned Komac. “I never want anybody else to feel that way if there was a potential for me to help.” She became an advocate for helping others fighting addiction, is an addiction coach, and has served as the executive director of an addiction recovery center.

Still, she wanted to help with the difficult and painful detox stage. It is an essential step for individuals with a substance use disorder as it addresses the physical dependence on a substance, making it possible to proceed with the psychological and behavioral aspects of recovery.

Komac had a successful career in private equity, mergers and acquisitions, roll-ups, and distressed assets and wanted to address the need for more innovation in the substance use disorder (SUD) space.

“We've known for quite some time that there's a neurological component,” said Komac. “I always say it's a biological brain hijacking that's taking place. And we don't really see anything in the space designed to address that biological brain hijacking. Addressing it needs to be done at the very outset of the process.”

In 2022, nearly 110,000 people died from drug overdoses in the United States—a new high —fueled by synthetic opioids. Dealing with withdrawal is traumatic. “Imagine the worst case of the flu you have ever had and multiply by 100,” exclaimed Komac. Detoxing is the number one barrier to people not getting into treatment.

Bryleos aims to create a therapeutic tool that mitigates withdrawal symptoms: not just opiate but methamphetamine, alcohol, and combinations of substances.

The active primary ingredient in Bryleos’ formulation is nicotinamide adenine dinucleotide (NAD). NAD is a pivotal molecule governing crucial functions, such as enzyme activity, DNA repair, oxidative stress, inflammation, and many costly chronic diseases.

IV NAD+ has been an effective way to break free from addiction for years—but it's not ideal. High doses are needed and administered over 10 days in the form of a painful intravenous injection that can be cost-prohibitive.

Komac decided to formulate an oral treatment. Bryleos' innovative patent-pending oral composition of NAD+ offers a more accessible solution, enabling individuals to treat their addiction from home without needing an IV or a hefty price tag.

A double-blind, placebo-controlled BNAD101 Proof-Of-Concept (POC) trial conducted among 60 people at the Institute for Systems Biology validated the potential of BNAD101, an oral treatment, in reducing withdrawal symptoms within just five days. This revolutionary breakthrough could make an invaluable difference in millions suffering from substance dependence. “Our next phase will be our Phase One study once our IND [Investigational New Drug] is filed with the FDA," said Komac.

“The biggest challenge has been that the Food and Drug Administration is just really backed up,” said Komac. If she could wave a magic wand, she would speed up how therapeutics are approved and develop a more collaborative relationship with the FDA. Working more closely with the FDA to accelerate approval processes was done in developing treatments for Covid-19. However, stigma remains around treating substance abuse.

Clearly, the government must take more concrete action to address substance use disorder and withdrawal. The same strategies have been employed for over two decades, yet the problem has only worsened. More funding should be allocated towards this sector to develop innovative solutions.

Komac has surrounded herself with pragmatic advisors. “I know my executive style and know when I'm a good match for people,” said Komac. She met several of her advisors when she went through one of Springboard Enterprises’ accelerator programs. It is a nonprofit with the mission to accelerate the growth of entrepreneurial technology and life sciences companies led by women through access to essential resources and a global community of experts. Its network helped Komac hone its message, protect Bryleos' intellectual property, and solve challenges that arise.

How are you leveraging your life experiences to develop products and services?