[Edaily Reporter NA EUN-KYUNG ] Inventage Lab Inc., a drug delivery platform company, announced on the 21st that it has received a registration decision from the U.S. Patent and Trademark Office (USPTO) for a patent related to “IVL3004,” a long-acting injectable drug for the treatment of substance use disorders.

IVL3004 is a once-monthly injection whose active ingredient is naltrexone, used to treat alcohol and opioid dependence. This patent protects a microparticle formulation and manufacturing technology that suppresses initial excessive drug release while ensuring a steady release over one month. The patent also covers naltrexone dosages exceeding 240 mg but less than 310 mg. The approved dosage for “Vivitrol,” a competing product from Alchemys, is 380 mg.

Inventage Lab Inc. had previously secured a U.S. patent covering the composition and particle characteristics of naltrexone microparticles. With this latest patent, the company has expanded its scope of protection to include pharmacokinetic performance, dosage, and the manufacturing process.

IVL3004 aims to maintain effective blood concentrations for four weeks at a lower dose than Vivitrol. In a Phase 1 clinical trial, 34 healthy adults were randomized to receive either 380 mg of Vivitrol or 300 mg or 380 mg of IVL3004. According to results released by the company, the duration of injection site adverse reactions was 3.8 days and 4.9 days in the IVL3004 groups, respectively—shorter than the 18.2 days observed in the Vivitrol group. However, as these are preliminary clinical results, they must be confirmed in subsequent clinical trials.

Inventage Lab Inc. plans to proceed with a Phase 2 clinical trial following regulatory consultations with the U.S. Food and Drug Administration (FDA). This patent will also be utilized in future global technology transfers and joint development initiatives.