Vectura has announced results from a pharmacokinetic study of its VR647 nebulized budesonide inhalation suspension in asthma patients aged 4 to 8 and a methodology study of the use of a mouthpiece with the VR647 nebulizer (the Akita Jet nebulizer) by children aged 1 to 4. In January 2017, Vectura announced that it had received FDA approval of its IND for pediatric studies of VR647.
The PK study enrolled 17 pediatric asthma patients and compared 3 doses of VR647 budesonide inhalation suspension to a 1 mg dose of budesonide delivered by a conventional jet nebulizer. the methodology study enrolled 40 children.
According to Vectura, the PK study demonstrated the potential of the VR647 system to reduce budesonide treatment time by at least half and to result in the same lung deposition as the currently marketed system with a smaller delivered dose.
The methodology study found that children from ages 2 to 4 were able to use the mouthpiece with the nebulizer. For children under age 2, the company said that it is developing a facemask.
Vectura Executive VP and Chief Medical Officer Gonzalo de Miquel said, “There are very few approved treatment options for children under 5 years of age. The results of these studies support Vectura’s confidence in our wholly-owned VR647 product as a more convenient treatment option for children. This product has the potential to reduce treatment times and the steroid burden for this patient population, without compromising exposure or safety. We look forward to outlining Phase 3 plans with the FDA at the end of the year.”
Read the Vectura press release.
