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Teva and Alexza Announce Teva’s License to Market ADASUVE® in the U.S.
Loxapine (Loxapac, Loxitane)
is a typical antipsychotic medication, used primarily in the treatment of schizophrenia. It is a member of the dibenzoxazepine class and structurally related to clozapine (which belongs to the chemically akin class ofdibenzodiazepines). Several researchers have argued that Loxapine may behave as anatypical antipsychotic.
Loxapine may be metabolized by N-demethylation to amoxapine, a tetracyclic antidepressant.
Adasuve® (loxapine) inhalation powder is approved in the U.S. for the acute treatment of agitation associated with schizophrenia and bipolar disorder
May 8, 2013
Teva Pharmaceuticals USA, Inc., a subsidiary of Teva Pharmaceutical Industries Ltd (NYSE: TEVA), and Alexza Pharmaceuticals, Inc. (NASDAQ: ALXA) announced today that the companies have entered into an exclusive U.S. license and supply agreement for ADASUVE (loxapine) inhalation powder 10 mg for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. Teva will be responsible for all U.S. commercial and clinical activities for ADASUVE, including U.S. post-approval clinical studies, and has gained rights to conduct additional clinical trials of ADASUVE for potential new indications in neurological disorders. Alexza will be responsible for manufacturing and supplying ADASUVE to Teva for commercial sales and clinical trials.
About Alexza Pharmaceuticals, Inc.
Alexza Pharmaceuticals is focused on the research, development and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions, including agitation, acute repetitive seizures and insomnia. Alexza’s products are based on the Staccato®system, a hand-held inhaler that is designed to deliver a drug aerosol to the deep lung, providing rapid systemic delivery and therapeutic onset, in a simple, non-invasive manner.
Alexza gets EU thumbs-up for Adasuve, Loxapine
LOXAPINE
2-Chloro-11-(4-methylpiperazin-1-yl)dibenzo[b,f][1,4]oxazepine
FEBRUARY 22, 2013
Alexza Pharmaceuticals of the USA and partnerFerrer are celebrating after getting the green light for their inhaled antipsychotic Adasuve.
The European Commission has granted marketing authorisation to Adasuve (loxapine) for the rapid control of mild-to-moderate agitation in adults with schizophrenia or bipolar disorder. The approval is based on two Phase III studies involving over 650 patients which showed that the drug demonstrated statistically significant reductions in agitation from baseline compared to placebo.
The approval requires that patients receive regular treatment immediately after control of acute agitation symptoms, and that Adasuve is administered only in a hospital setting. Also, short-acting beta-agonist bronchodilator treatment should be available for treatment of possible severe respiratory side-effects.
Alexza chief executive Thomas King noted that Adasuve is the first authorised non-injectable therapy for these indications, noting that it will be launched on both sides of the Atlantic in the third quarter – US approval was granted in December.
Spain’s Ferrer has Adasuve rights in Europe, Latin America, Russia and the Commonwealth of Independent States countries. Chief executive Jordi Ramental said the focus for the initial EU launch will be Germany and Austria in 2013, adding that “at the same time, we are compiling the registration dossiers for the non-EU countries in our licensed territory”.
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Loxapine (Loxapac, Loxitane) is a typical antipsychotic medication, used primarily in the treatment of schizophrenia. It is a member of the dibenzoxazepine class and structurally related to clozapine (which belongs to the chemically akin class of dibenzodiazepines). Several researchers have argued that Loxapine may behave as an atypical antipsychotic.[1]
Loxapine may be metabolized by N-demethylation to amoxapine, a tetracyclic antidepressant.[2]
Dosage
The typical starting dosage is 10 mg twice daily; usual dose range 30–50 mg twice daily; maximum recommended dosage is 250 mg per day. The US Food and Drug Administration (FDA) has approved loxapine ( Adasuve , Alexza Pharmaceuticals) inhalation powder 10 mg for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. [4]
Schmutz, J.; Kunzle, F.; Hunziker, F.; Gauch, R.; Helv. Chim. Acta 1967, 50, 245.
- Glazer WM (1999). “Does loxapine have “atypical” properties? Clinical evidence”. The Journal of Clinical Psychiatry 60 (Suppl 10): 42–6. PMID 10340686.
- Cheung SW, Tang SW, Remington G (March 1991). “Simultaneous quantitation of loxapine, amoxapine and their 7- and 8-hydroxy metabolites in plasma by high-performance liquid chromatography”. Journal of Chromatography 564 (1): 213–21. doi:10.1016/0378-4347(91)80083-O. PMID 1860915.
- Sperry L, Hudson B, Chan CH (March 1984). “Loxapine abuse”. The New England Journal of Medicine 310 (9): 598. doi:10.1056/NEJM198403013100920. PMID 6694719.
- Harrison, Pam: Inhalant Approved for Agitation in Bipolar I, Schizophrenia. Medscape. Dec 24, 2012. “Clozapine and loxapine for schizophrenia”. Drug and Therapeutics Bulletin 29 (11): 41–2. May 1991. PMID 1747161.
- Chakrabarti A, Bagnall A, Chue P, et al. (2007). Chakrabarti, Abhijit. ed. “Loxapine for schizophrenia”. Cochrane Database of Systematic Reviews (Online) (4): CD001943. doi:10.1002/14651858.CD001943.pub2. PMID 17943763.
- Brennand, Kristen; Anthony Simone, Jessica Jou, Chelsea Gelboin-Burkhart, Ngoc Tran, Sarah Sangar, Yan Li, Yangling Mu, Gong Chen, Diana Yu, Shane McCarthy, Jonathan Sebat & Fred H. Gage (13 April 2011). “Modelling schizophrenia using human induced pluripotent stem cells”. Nature 473 (7346): 221–5. doi:10.1038/nature09915. PMID 21490598.
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