2011年举行的第63届美国神经病学年会上，那些备受关注的偏头痛候选药物并没有披露更多新的临床数据。然而，各大公司都忙于宣传。Allergan公司强调Botox对慢性偏头痛患者的强大功效，MAP制药公司和Zogenix公司致力向与会人员普及针对急性偏头痛的超短效技术带来的益处，默克公司则披露了其降钙素基因相关肽（CGRP）受体拮抗剂telcagepant一些令人鼓舞的心血管安全性数据。

Levadex证明了对偏头痛的疗效
       
Levadex，由MAP制药研发，它是一种双氢麦角胺衍生物（DHE）麦角胺的吸入剂型，采用了该公司专有的Tempo药物输送技术，用于治疗潜在的急性偏头痛发作。DHE用于非吸入方法治疗偏头痛已经超过了60年。在此前的临床研究中，Levadex已被证实和静脉注射的DHE具有相似的血浆药物达峰值时间（Tmax），但血药浓度峰值（Cmax）更低，并且恶心反应较少。
       
在完成III期临床功效试验后，MAP制药又进行了额外的四个临床试验——开放性安全试验，药代动力学研究，药效研究和QT间期试验——用于提交新药申请（NDA）的补充，MAP制药计划将在今年的上半年提交Levadex的NDA。
       
MAP制药在AAN2011年会上披露了这四个额外试验的一些数据。海报展示主要集中描述一个具有良好安全性和药动学特征的Levadex。

Shashidhar Kori博士强调了当偏头痛发作时，使用Levadex的疗效要优于triptans（翠普登）。这项研究的理由是，很多病人往往是在偏头痛发作的时候才服药，而试验证实，triptans在早期介入的疗效最好，晚期介入疗效不佳。一项III期临床试验（n=771）的post-hoc分析表明，Levadex治疗中度至重度急性偏头痛效果显著，即使是在偏头痛发作八个小时后服用，仍有效果。试验展示的效果，让Levadex与其他紧急疗法相比，具有难以比拟的优势。

LEVADEX; for the Potential Treatmentof Migraine
LEVADEX orally inhaled migraine therapy is a novel migraine therapy in Phase 3 development. Patients administer LEVADEX themselves using the company's proprietary TEMPO; inhaler. LEVADEX has been designed to be differentiated from existing migraine treatments. It is a novel formulation of dihydroergotamine (DHE), a drug used intravenously in clinical settings to effectively and safely treat migraines. Based on clinical results, the company believes that LEVADEX has the potential to provide both fast onset of action and sustained pain relief and other migraine symptom relief in an easy-to-use and non-invasive at-home therapy.
In the efficacy portion of our first Phase 3 clinical trial, LEVADEX met all four primary endpoints, showing statistically significant improvement in pain relief, freedom from phonophobia (sensitivity to sound),freedom from photophobia (sensitivity to light) and freedom from nausea.
Additional endpoints showed that LEVADEX provided rapid and sustained pain relief for up to 48 hours after dosing.
Migraine Headaches: A Debilitating Neurological DisorderAccording to the National Headache Foundation (NHF), approximately 30 million people in the United States suffer from migraine, a chronic and debilitating neurological disorder. Common symptoms of migraine include recurrent headaches, nausea, vomiting,phonophobia and photophobia.

According to NHF, most migraines last between four and 24 hours, but some last as long as three days. On average, migraine sufferers experience 1.5 migraine attacks monthly, although 25 percent of them experience one or more attacks weekly, according to published studies. The economic burden of migraine remains substantial despite existing treatments, with the direct and indirect costs of migraine in the United States estimated at over $20 billion annually.
Limitations of Current Migraine TherapiesThe type of migraine treatment pursued depends on frequency and severity of the headache, speed of onset and previous response to medication.
Triptans are the class of drugs most often prescribed for migraine. Other forms of DHE are also available to migraine sufferers, including IV and nasal. However, migraine patients report that currently approved drugs do not fully meet their needs due to:Slow onset of action and short duration of effect:While triptans have improved the treatment of migraine, their onset of pain relief is relatively slow.
Estimated onset of significant pain relief with oral triptans occurs between 45 and 90 minutes after dosing. Nasal administration of DHE generally takes 30 to 60 minutes to provide significant pain relief. Inconsistent response:Approximately 30 to 40 percent of migraine patients do not respond fully to the first triptan prescribed, and many migraine sufferers do not respond to triptans at all. These patients currently have few satisfactory alternatives.
Nasal delivery may lead to inconsistent dosing for many reasons, including difficulties in administration and poor absorption.
Unacceptable side effect profiles:
Triptans may constrict arteries, which may raise blood pressure.
Nausea is a common side effect of intravenous DHE administration. Nasal administration of DHE may result in unpleasant taste, and can cause inflammation of the nasal membrane.
Our Potential Solution:

LEVADEX
LEVADEX is designed to incorporate the multiple beneficial mechanisms of action that allow DHE to block initiation of migraine, limit pain, reduce inflammation and stop a migraine at any point in the migraine cycle. Based on research to date, including the FREEDOM-301 trial, the company believes the unique pharmacokinetic profile of LEVADEX has the potential to effectively treat migraines, while minimizing the side effects commonly seen with DHE and other currently available medicines.
Based on our clinical studies, we believe LEVADEX may provide patients with the following benefits when compared to existing migraine therapies:Rapid and long-lasting relief:In our Phase 3 trial, treatment with LEVADEX provided significant pain relief in as fast as 30 minutes. While not statistically significant, 50
percent more of the patients receiving LEVADEX than the patients receiving placebo reported pain relief at 10 minutes in our Phase 3 trial. In Phase 3, LEVADEX also provided pain relief for up to 48 hours. Broadly efficacious:Based on historical DHE use, LEVADEX may provide a higher response rate and has the potential to treat patients who have not previously responded
to other therapies, such as triptans. Convenient and consistent delivery:LEVADEX is non-injectable and easy to use, resulting in increased patient comfort and compliance. Our Phase 2 and 3 trials were performed in the home, without clinical supervision and with minimal training. Administration of LEVADEX allows for consistent dosing directly to the lung with fast and accurate systemic absorption.
Low side effects:In our Phase 2 and 3 trials to date, treatment with LEVADEX was well-tolerated, with no serious adverse events reported. Drug-induced nausea was low and migraine-associated nausea also decreased with treatment.