피망 바카라 Lab completes GLP toxicity studies for IVL5005, its long-acting injectable medical cannabis

[by Jin, Yu Jeong] 피망 바카라 Lab announced on December 3 that ‘IVL5005 (development code),’ its long-acting injectable candidate containing the medical cannabis ingredient ‘cannabidiol (CBD),’ has completed GLP toxicity studies.

피망 바카라 Lab is developing IVL5005 in partnership with Yuhan Health & Living and noted that it is the first company in Korea to complete GLP toxicity testing for a CBD-based drug candidate. The company is currently in discussions with global partners regarding clinical development strategies.

Epidiolex, a CBD-based rare disease treatment approved by the U.S. Food and Drug Administration (FDA), is indicated for rare pediatric epilepsy (LGS, DS) and is also available in Korea as an imported medication. 피망 바카라 Lab reported that it has conducted preliminary consultations with a global regulatory adviser in preparation for seeking ‘Orphan Drug Designation (ODD)’ from the FDA for IVL5005.

According to 피망 바카라 Labs, the FDA indicated that long-acting injectables with durations exceeding one month may be unsuitable for pediatric use from a convenience and safety perspective. In particular, given that Epidiolex is currently administered orally three or more times per day, the FDA reportedly noted that an injection interval of one to two weeks would be sufficient to offer a meaningful improvement in convenience.

The company further noted that the FDA's considerations took into account clinical preferences regarding the use of long-acting injectables lasting more than one month in one-year-old infants, as well as the rarity of regulatory approval for pediatric injectables with such extended durations. In response, 피망 바카라 Labs actively incorporated the FDA's feedback into its clinical development strategy, narrowing its focus to a one- to two-week dosing interval. The company added that it is currently refining its target product profile (TPP) to align with the FDA’s regulatory evaluation criteria.

Furthermore, 피망 바카라 Lab emphasized that, contrary to recent reports, its independently developed chronic epilepsy animal model demonstrated robust anticonvulsant efficacy for more than three weeks following a single dose of IVL5005. The company explained that these findings reflect the balance between safety and efficacy that is essential in developing treatments for rare pediatric epilepsies.

피망 바카라 Lab's microfluidic-based long-acting injectable platform, ‘IVL-DrugFluidic,’ supports a wide range of release durations, from two weeks to six months (up to 12 months for veterinary applications), depending on the characteristics of the drug and development objectives. Leveraging this platform, the company is advancing global development of IVL5005 alongside several additional pipeline candidates.

"Recent media reports have created market confusion by misrepresenting the company’s development strategy and the context of its regulatory discussions. These claims are unfounded. Development of IVL5005 is proceeding as planned in consultation with Yuhan Care," an 피망 바카라 Lab official stated.

"We will continue to work closely with the FDA and global drug development experts to ensure the smooth global advancement of our pipeline. We remain committed to providing transparent information to our shareholders grounded on scientific evidence and regulatory standards," the company further added.