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首页 » 梯瓦 » 梯瓦推出全球首个口腔吸入性精神分裂症药物Adasuve

梯瓦推出全球首个口腔吸入性精神分裂症药物Adasuve

来源:生物谷 2014-03-05 03:54

2014年3月4日讯 /生物谷BIOON/ --仿制药巨头梯瓦(Teva)3月3日宣布,在美国推出Adasuve(loxapine,洛沙平,10mg)吸入性粉末,该药是全球首个用于精神分裂症和双相I型障碍成人患者激越(agitation)急性治疗的经口吸入性药物。

Adasuve通过Alexza公司专有的Staccato药物递送系统给药。这种创新的药物装置组合产品,使患者通过吸入热生成( thermally-generated)的Adasuve气溶胶,向肺部进行快速的系统性递送(systemic delivery)。给药后,Adasuve能够快速吸收,大约2分钟内达到最高血药浓度。

Adasuve对急性激越的疗效在2项临床试验中得到证实:一项试验在精神分裂症患者中开展,另一项在双相I型障碍患者中开展。接受Adasuve治疗的患者,激越实现了统计学意义的显著减少,同时,在给药后10分钟便可观察到疗效。(生物谷Bioon.com)

英文原文:Teva Launches ADASUVE in U.S.

The first and only orally inhaled medicine for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults

JERUSALEM--(BUSINESS WIRE)--Mar. 3, 2014-- Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) announced today the commercial launch of ADASUVE? (loxapine) inhalation powder 10 mg, the first and only orally inhaled medicine for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

ADASUVE? is administered through Alexza Pharmaceuticals' (NASDQ:ALXA) innovative proprietary Staccato? single-use, hand held drug delivery technology system. This new drug-device combination product provides rapid systemic delivery by inhalation of a thermally-generated aerosol of loxapine, a first generation antipsychotic, to the lung. Administration of ADASUVE? results in rapid absorption of loxapine, with a maximum plasma concentration achieved in approximately 2 minutes.

Efficacy was demonstrated in two clinical trials in acute agitation: one in schizophrenia and one in bipolar I disorder. Patients receiving ADASUVE? experienced a statistically significant reduction in agitation at two hours, with an effect seen as early as ten minutes post-dose.

Due to the risk of bronchospasm that has the potential to lead to respiratory distress and respiratory arrest, ADASUVE? is contraindicated in patients with a current diagnosis or history of asthma, chronic obstructive pulmonary disease (COPD), or other pulmonary disease associated with bronchospasm and is only available through a restricted program called the ADASUVE? Risk Evaluation and Mitigation Strategy (REMS). ADASUVE? must be administered only in a REMS-enrolled healthcare facility that has immediate access on-site to equipment and personnel trained to manage acute bronchospasm, including advanced airway management (intubation and mechanical ventilation).

“Existing treatment options for patients with agitation associated with schizophrenia or bipolar I disorder are limited to oral tablets or injectable modes of administration, sometimes requiring the use of restraints,” said Richard Jaffe, M.D., Medical Director for Research and Clinical Trials at the Belmont Center for Comprehensive Treatment Philadelphia, Pennsylvania, and a clinical trial investigator. “ADASUVE? is a drug-device combination that offers health care providers a new option to help manage agitation.”

Patients experiencing agitation associated with schizophrenia or bipolar I disorder often manifest behaviors that interfere with their care, such as threatening behaviors, escalating or urgently distressing behavior or self-exhausting behavior that lead clinicians to use rapidly absorbed antipsychotic medications to help control the agitation quickly. Agitation associated with schizophrenia and bipolar I disorder is estimated to result in approximately 7 million episodes that end up in an acute emergency treatment setting each year. Acute agitation can increase in severity and escalate unpredictably.

“The availability of orally inhaled ADASUVE? provides a rapid onset of action that quickly improves symptoms for patients and gives providers in enrolled hospitals another treatment choice,” said Michael McHugh, Vice President and General Manager, Teva Select Brands and Teva Women’s Health. “As part of our ongoing commitment to enhancing patient care and bringing new therapies and delivery systems to the market that fit within our areas of expertise, Teva is pleased to launch this new treatment choice that is aligned with Teva’s New Therapeutic Entities (NTE) program.”

Two phase three short-term clinical efficacy trials demonstrated significant improvement in agitation at two hours, in patients with schizophrenia or bipolar I disorder treated with ADASUVE?. These studies demonstrated a 49 percent reduction in agitation symptoms from baseline in schizophrenia patients, as compared to 33 percent in placebo, and 53 percent reduction in bipolar I patients, as compared to 27 percent in placebo. Improvement was rapidly achieved at 10 minutes post-dose with a 19 percent reduction in agitation symptoms from baseline in schizophrenia patients and a 23 percent reduction in bipolar I patients, both as compared to 10 percent in placebo.

Please see additional important safety information including boxed warnings and REMS Program information below. The most common adverse reactions (greater than at least 2% in the treated group and greater than in the placebo group) in short-term, placebo-controlled trials were dysgeusia (abnormal taste), sedation and throat irritation.

Teva licensed the U.S. commercial rights to ADASUVE? in May 2013 from Alexza Pharmaceuticals, inventor and developer of the Staccato? system and of ADASUVE?. Under the terms of the license and supply agreement, Teva is responsible for all U.S. commercial and clinical activities including U.S. post-approval clinical studies. Alexza is responsible for manufacturing and supplying ADASUVE? to Teva for commercial sales and clinical trials. ADASUVE is currently available through a select distribution network.

ADASUVE? (loxapine) inhalation powder, for oral inhalation use, is a typical antipsychotic indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. Efficacy was demonstrated in two trials in acute agitation: one in schizophrenia and one in bipolar I disorder.

Limitations of Use: As part of the ADASUVE? REMS Program to mitigate the risk of bronchospasm, ADASUVE ? must be administered only in an enrolled healthcare facility.

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