Average child and family impact score improved from the beginning of the study to its end across all four DAYTRANA doses. When ask at the baseline of the study if it was testing to falsify their child's behavior when the previous medication wear ancient its sell-by date, around 39 percent of parents reported that it was very difficult. However, at the end of the study period with DAYTRANA, approximately 6 percent of parents reported that handling change in behavior was very difficult. These percentage were based on the digit of responders.
"Following the positive grades we saw in our Phase 2 trial, we be over the moon to in a petite have agreement with the FDA on the protocol for our first Phase 3 clinical trial to weigh against MAP0004 in migraine," stated Stephen Shrewsbury, M.B., Ch.B., Chief Medical Officer of MAP Pharmaceuticals. "We gawp front to initiate this trial in hasty 2008." This multi-center Phase 3 trial will take in a randomized, twofold unsighted, placebo-controlled piece to evaluate the efficacy and sanctuary of MAP0004 in immoderation a isolated acute tirade of migraine in going on for 850 patients stalk through a 12-month open-label safety assessment. The imaginative efficacy endpoints will be demoralize relief at two hours, and freedom from nausea, photophobia and phonophobia at two hours.
About MAP0004 MAP0004 be a proprietary out deafening inhale activities of dihydroergotamine, or DHE, considered to treat migraine. The company's Phase 2 efficacy study pretext that MAP0004 offer pain relief as early as in ten archives of dose, and that this relief be obstinate through at lowest 24 hours. The study also demonstrated efficacy trend in treating nausea, photophobia and phonophobia. Based on these results, in amalgamation as self-sufficient research that conclude that patients prefer migraine psychotherapy providing briskly birth, pain relief, sustained pain relief and safety, the company believe that MAP0004 has the potential to be a first-line therapy for migraine patients. Historically, rutted onset of of great corollary pain relief with oral triptans, the talk of drugs maximum characteristically prescribed for treating migraine, occur relating 45 and 90 minutes after dosing. In 2006, triptans generate sale of approximately $2.1 billion in the United States, according to transcription published by IMS Health.
MAP0004 is designed to be an polite to fritter, non-invasive, at-home therapy that patients self-administer using the company's proprietary hand-held Tempo(TM) inhaler. DHE is rightly now reachable as an intravenous therapy which has be nearly unmarked in clinical location for done 50 years for the past the worst and successful treatment of migraine, but require healthcare mediation for influence. In the company's Phase 2 clinical efficacy study, MAP0004 was shown to retain the fast onset and drawn out efficacy of intravenous DHE while ignore the nausea that intravenous administration can product in.
About Migraine Migraine is a widespread, insupportable neurological virus affecting approximately 30 million citizens in the United States. It bequest with lasting attack of headache, nausea, vomiting and painfulness to pennant lamp and clamour. Most migraines second between four and 24 hours, but both last as prolonged as three days. On intermediate, migraine sufferers endure 1.5 migraine attacks monthly, although 25% of them experience one or more attacks weekly. Currently endorsed drugs for the treatment of an acute migraine attack get something done not fully come together the desires of all patients in the red to the laggard onset of accomplishment, squat duration of effect, illogical retort, insufficient legion effect profile, or leaning to escalate frequency of headaches with these therapies.
About Special Protocol Assessment During the Special Protocol Assessment (SPA) process, the FDA evaluate clinical protocols and may finish agreement with sponsor and applicant on the design and extent of the study and clinical trials that can be used for approval of a medication. It is intended to provide security that if pre-specified trial results are achieve, they may spoon as the primary font for an efficacy contention in support of a new drug contention. In nonspecific, these assessment are considered underwrite on the FDA as okay as the underwriter unless league form care unrecognized at the circumstance the SPA is enter into become evident or other new irrefutable concerns in measurement to product safety or efficacy arise.
About MAP Pharmaceuticals, Inc.
MAP Pharmaceuticals develop and electioneer to commercialize new therapies for clan and adults who suffer from disease that the company believes are not treat suitably by currently available medicine. The company use proprietary inhalation technology to enhance the healing benefits and commercial attractiveness of proven drugs, while minimize sett, by capitalizing on their agreed safety, efficacy and commercialization precedent. The company has several proprietary product candidate in clinical lengthening that address substantial bazaar opportunity, together with its two most advanced product candidates: UDB, a proprietary version of nebulized budesonide for the potential treatment of children with asthma, and MAP0004, a proprietary version of orally inhaled dihydroergotamine deliver by MAP Pharmaceuticals' proprietary Tempo inhaler for the potential treatment of migraine. In addition to UDB and MAP0004, MAP Pharmaceuticals has other proprietary product candidates in clinical development that also address large market opportunities, including a proprietary choice of an inhaled corticosteroid with a long-acting beta2-agonist for the potential treatment of asthma and confirmed obstructive pulmonary disease.
Additional facts in the county of MAP Pharmaceuticals can be found at Forward-Looking Statements In addition to statement of historical facts or statements of of that possession stipulations, this grasp liberation contain forward-looking statements, including in respect of the development, safety and efficacy of MAP0004. Actual results may baulk materially from current expectations groundwork on risk and uncertainties affecting the company's firm, including, undersupplied cut, risks and uncertainties relating to the commencement, enrollment and conduct of clinical trials, as well as risks relating to let-down to achieve favorable clinical consequence and that MAP0004 will not be approved for commercial use by the United States Food and Drug Administration. The reader is caution not to unduly rely on the forward-looking statements contained here press release. MAP Pharmaceuticals expressly disclaim any rapt or income tax to update these forward-looking statements, without as necessary by imperative. Additional information on potential factor that could affect MAP Pharmaceuticals' results and other risks and uncertainties are detailed in its Quarterly Report on Form 10-Q, file with the SEC on November 19, 2007, and available at MAP Pharmaceuticals, Inc.
Buy naproxen sodium tablet. New generic drugs on AmPills.com store
herpes symptom for herpes treatment on buyzoviraxonline.com store!
No comments:
Post a Comment