Avecho commences CBD softgel manufacturing for pivotal Phase III insomnia study
Avecho has today announced it has commenced manufacturing activities for its oral CBD softgel capsule with US-based Contract Manufacturing Organisation (CMO), Procaps Group.
Procaps has a direct presence in 13 countries in the Americas where it develops, manufactures, and markets over-the-counter (OTC) pharmaceutical products and prescription pharmaceutical drugs (Rx), nutritional supplements and high-potency clinical solutions.
Avecho is currently raising capital to support the commencement of its pivotal Phase III study testing its oral CBD softgel capsule for the treatment of insomnia. The study is the largest of its kind to date, and will enrol 540 patients across three treatment groups to compare nightly CBD doses of 75 and 150 mg CBD with placebo over an 8 week dosing period.
Procaps will produce 290,000 capsules to support the trial. In addition, they will manufacture three registration batches of the CBD capsule, which will be placed on formal stability studies to define the shelf life of the commercial product. Documentation from these batches is a key component of the registration package to be submitted to regulatory agencies such as the FDA and TGA.
Avecho CEO, Dr Paul Gavin, said:
“We are delighted that Procaps will be joining us on this journey as we prepare for this defining late-stage clinical trial, which will be an exciting milestone for our Company and the biotechnology industry at large. Importantly for Avecho, Procaps are a manufacturing option for CBD capsules able to be sold in further consumer markets.”