The CHMP Delivers a Positive Opinion Recommending Grant of Marketing Authorization for ADASUVE® (Staccato® Loxapine) in the European Union
and , /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) and , S.A., today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending that ADASUVE ( loxapine) be granted European Union (EU) centralized marketing authorization. The CHMP recommends that ADASUVE be authorized in the EU for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder. Patients should receive regular treatment immediately after control of acute agitation symptoms. The recommendation by the CHMP is that ADASUVE should be administered only in a hospital setting under the supervision of a healthcare professional. Short-acting beta-agonist bronchodilator treatment should be available for treatment of possible severe respiratory side-effects, such as bronchospasm.
The positive opinion was based on Alexza's clinical development program that included two randomized, multicenter Phase 3 pivotal studies of ADASUVE, which enrolled 344 adult patients with schizophrenia and 314 adult patients with bipolar disorder. These two clinical trials demonstrated statistically significant reductions in agitation from baseline compared to placebo. Alexza estimates that as many as 8 million adults in the EU alone suffer from schizophrenia or bipolar disorder. Agitation is a common symptom for these patients.
"The recommendation for approval from CHMP moves us one step closer to bringing this novel treatment to patients with agitation," said , PhD, Executive Vice President and Chief Scientific Officer, "We believe that ADASUVE may provide an important new therapeutic option as the first rapid and non-invasive treatment to address episodes of agitation."
The CHMP positive opinion will now be forwarded to the European Commission, which has the authority to grant marketing authorization for medicinal products in the EU. The marketing authorization expected to be delivered by the European Commission would be applicable in all 27 EU Member States, plus , and Norway. A decision is expected from the European Commission in the first quarter of 2013. Alexza filed the ADASUVE Marketing Authorization Application (MAA) with the EMA in .
ADASUVE combines Alexza's proprietary system with loxapine, an antipsychotic medicinal product. The system is a hand-held inhaler that delivers a drug aerosol to the deep lung that results in IV-like pharmacokinetics and rapid systemic effects. In two Phase 3 clinical trials of more than 600 patients with schizophrenia or bipolar disorder, ADASUVE provided statistically significant reduction in the symptoms of agitation compared to placebo. The most common side effects observed in these clinical trials were dysgeusia, sedation/somnolence and dizziness.
ADASUVE is not authorized for marketing in the US. Alexza has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration, which is currently under review with a Prescription Drug User Fee Act (PDUFA) goal date of , 2012.
Ferrer is partnered with Alexza for ADASUVE in , , and the Commonwealth of Independent States. Ferrer is a privately-held European R&D-based pharmaco-chemical and medical device company headquartered in , Spain. Founded in 1959, the group encompasses today 45 companies developing its activities in , , , , and the United States. In total, Ferrer's human healthcare products are being commercialized in 93 countries through 26 direct subsidiaries (including Joint Ventures) and 70 partners and distributors.
Ferrer carries out activities throughout the full value-chain of the pharma business, from R&D to international marketing, including fine chemicals development and both raw material and pharmaceutical product manufacturing. For this purpose, Ferrer has research centres in and , as well as manufacturing sites in and .
For more information about Ferrer, visit the Company's web site at www.ferrergrupo.com.
Based in , Alexza is a pharmaceutical company focused on the research, development and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions. ADASUVE ( loxapine), Alexza's lead program, is currently under review in by the U.S. Food and Drug Administration for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.
The system, vaporizes unformulated drug to form a condensation aerosol that, when inhaled, allows for rapid systemic drug delivery through deep lung inhalation. The drug is quickly absorbed through the lungs into the bloodstream, providing speed of therapeutic onset that is comparable to intravenous administration, but with greater ease, patient comfort and convenience.
ADASUVE and Staccato are registered trademarks of Alexza Pharmaceuticals, Inc.
SOURCE Alexza Pharmaceuticals, Inc.