Alexza Pharmaceuticals has announced that it will develop Staccato versions of ropinirole, a dopamine agonist, for the treatment of restless leg system (AZ-008) and for the treatment of hypomobility during OFF episodes in Parkinson’s disease (AZ-009). The Staccato system uses heat to aerosolize pure API for inhalation. The company said that it also plans to begin a Phase 2a proof of concept study of Staccato alprazolam (AZ-002) for the treatment of repetitive seizures before the end of 2014.
According to Alexza, “there are potential advantages from the co-development of AZ-008 and AZ-009, as the two product candidates may be able to utilize the same preclinical and toxicology program, Investigational New Drug (IND) submission and initial Phase 1 clinical trial. Beginning with planned Phase 2 clinical studies, Alexza expects to separate the two product candidates into distinct clinical development programs for the two different patient populations.”
Alexza Executive VP, R&D and Chief Scientific Officer James V. Cassella said, “On the pipeline side, over the last nine months we have conducted a broad review of medical need in major therapeutic areas. Through this process, we identified a number of product concepts that aligned with our Staccato technology. We selected Staccato ropinirole as the basis of the next product candidates planned in our pipeline, based upon our belief of the need for better therapies for patients with RLS or PD. We feel that AZ-008 and AZ-009 may offer these two distinct patient populations an advantage over products available today.”
Alexza’s Adasuve Staccato loxapine was approved by the FDA for the treatment of agitation in patients with schizophrenia or bipolar I disorder in December 2012 and was launched in the US by Teva earlier this year. Adasuve was approved by the EU in February 2013 and was launched in Europe by Grupo Ferrer in July 2013.
Read the Alexza press release.
