Galen US has acquired US rights to Alexza Pharmaceuticals’ Adasuve inhaled loxapine for the treatment of agitation in patients with schizophrenia or bipolar I. Adasuve was approved by the FDA in December 2012 for use in certain healthcare facilities enrolled in the Adasuve REMS program only.
In May 2013, Teva announced that it had acquired US rights to Adasuve, and it launched the product in the US in March 2014. In November 2016, Alexza announced that it was reacquiring the US rights.
According to Galen, the FDA has approved product labeling changes and modifications to the REMS that will add some additional settings allowed to administer Adasuve. The company also said that it will increase distribution to emergency departments and psychiatric facilities.
Galen US General Manager Andrew Shales commented, “We are excited to add Adasuve to Galen’s comprehensive product portfolio as we continue to increase our US footprint. Adasuve will be our first priority for the foreseeable future because it is the only FDA-approved inhaled product for patients suffering escalating agitation associated with schizophrenia or bipolar I disorder. While other products are prescribed for this disorder, the only other agents approved for acute agitation in these patients are antipsychotics delivered via intramuscular injection, which is typically reserved for severely agitated patients. Adasuve is a fast-acting first-line treatment which is non-invasive. Galen is proud to provide Adasuve as an alternative option to serve both healthcare providers and patients.”
Alexza President and COO Tatjana Naranda said, “Alexza’s collaboration with Galen represents an important milestone for the millions of patients with schizophrenia or bipolar I disorder who seek treatment for their episodes of agitation every year. Adasuve is an effective product. Early feedback from physicians and patients corroborate the positive clinical profile we observed with Adasuve during its clinical development. It is an innovative medicine that provides an important option for physicians who treat patients with agitation associated with schizophrenia or bipolar I disorder.”
Grupo Ferrer, Adasuve’s distributor in the EU, Latin America and the CIS countries, acquired Alexza in 2016.
Read the Galen press release.
