Floraworks Announces Trucbn(TM) Readiness For The CMS Substance Access BEI Program With Full Clinical And Safety Substantiation

(MENAFN- Newsfile Corp) FloraWorks Announces TruCBN(TM) Readiness for the CMS Substance Access BEI Program with Full Clinical and Safety Substantiation TruCBN(TM) demonstrated statistically significant improvement in sleep quality in a published RCT and is supported by a full GLP safety package

April 09, 2026 8:00 AM EDT | Source: FloraWorks

Portland, Oregon--(Newsfile Corp. - April 9, 2026) - FloraWorks today announced that TruCBNTM 50 mg softgels are available to healthcare organizations evaluating sleep-focused hemp products for the CMS Substance Access Beneficiary Engagement Incentive (BEI) program.

In a published 1,020-person randomized, double-blind, placebo-controlled clinical trial, TruCBNTM 50 mg dose demonstrated statistically significant improvement in sleep quality.

Real-world evidence has also shown longer sleep duration, fewer night wakings, and next-day refreshment improving from 19.95% to 69.61%.

FloraWorks has also built the safety and documentation foundation needed for regulated evaluation. TruCBNTM is supported by a full GLP toxicology and genotoxicity package, including 90-day oral toxicity, Ames, and in vitro micronucleus studies. In the clinical trial, adverse events were comparable to placebo.

“We have been focused on translating cannabinoid science into clinically credible solutions. TruCBNTM reflects that approach, combining human clinical evidence with a growing understanding of sleep-wake biology, including cannabinoid interactions with key pathways like orexin signaling,” says Dr. Matthew A. Roberts, FloraWorks CSO.

FloraWorks has assembled implementation-ready documentation to support organizations preparing for CMS review. TruCBNTM is formulated as a 50 mg oral softgel and aligns with the non-inhalable format required under the program pathway.

"This program is an opportunity for the entire hemp-derived cannabinoid industry to prove it belongs in healthcare," says Alleh Lindquist, FloraWorks CEO. "We encourage healthcare organizations to set the bar high - published human trials, full safety data, and implementation-ready documentation. TruCBNTM was built to meet that standard, and we believe the more companies that rise to it, the stronger this program becomes for patients."

Poor sleep is one of the most persistent and undertreated problems in older adult populations, and available approaches often come with limitations around tolerability, dependence, or next-day effects. The BEI program creates a new pathway for physicians to address this gap with clinically substantiated, non-hormonal options within Medicare care settings.

Healthcare organizations interested in evaluating TruCBNTM for the CMS Substance Access BEI program can access further evaluation documentation here:

About FloraWorks

FloraWorks is a cannabinoid science company focused on clinically validated hemp-derived ingredients for regulated health channels. The company's platform spans human clinical trials, GLP toxicology, and quality-focused manufacturing and compliance systems. FloraWorks is headquartered in Portland, Oregon.

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Forward-Looking Statements

This press release contains forward-looking statements regarding regulatory pathways, commercial opportunities, product positioning, and potential adoption within emerging healthcare channels. Actual results may differ materially from those expressed or implied. FloraWorks undertakes no obligation to update forward-looking statements.

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Source: FloraWorks

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