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Under the terms of the agreement, Alexza and Symphony Capital established Symphony Allegro, Inc., which is providing funding to Alexza to accelerate clinical and other butalbital apap caffeinerelated development activities of Staccato loxapine (AZ-004 and AZ-104) and Staccato alprazolam (AZ-002). Alexza Pharmaceuticals is an emerging specialty pharmaceutical company focused on flonase spraythe development and commercialization of novel, proprietary products for the treatment of acute and intermittent conditions. About AZ-104 (Staccato loxapine) AZ-104 is the combination of Alexza's proprietary Staccato system with loxapine, a drug belonging to the class of compounds known as dopamine receptor antagonists. ALXA) announced today that it has initiated a Phase 2b clinical trial butalbital apap caffeinewith AZ-104 (Staccato loxapine) in patients with migraine headaches. Three doses will be evaluated in the clinical trial, placebo and two doses of AZ-104 (1.25 and 2.5 mg). Alexza Initiates AZ-104 (Staccato(R) Loxapine) Phase 2b Clinical Trial in Patients With Migraine Headaches MOUNTAIN VIEW, Calif., / - / -- Alexza Pharmaceuticals, Inc. Using the 4-point rating scale, the primary efficacy endpoint was pain-relief at 2 hours post-administration. These and other risks concerning Alexza's business are described in additional detail in the Company's Annual Report on Form 10-K for the year ended , and the Company's other Periodic and Current chemist order zithromaxReports filed with the Securities and Exchange Commission including the risks under the headings. Safety evaluations will also be made throughout the clinical trial period. AZ-104 and AZ-004 are being developed through Symphony Allegro, a product development partnership formed between Alexza and Symphony Capital, LLC. Forward-looking statements contained in this announcement are made as of this date, and the Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. The Staccato system technology is a hand-held, chemically-heated, single dose inhaler designed to generate and deliver excipient-free drug aerosol for deep lung delivery that results in IV-like pharmacokinetics. Data from this outpatient clinical trial will guide our future development plans for AZ-104 for the treatment of migraine headaches." About Acute Migraine Headaches According to the prescription drugs skin care products available in indiaNational Headache Foundation, approximately 13 million people in the United States have been diagnosed with migraine headaches. "We believe the potential value of the non-invasive nature and rapid onset of pharmacological action provided by our Staccato system is well-suited for migraine pain relief in the outpatient setting. The Company has previously announced positive results in two Phase 3 trials of AZ-004 and expects to submit a New Drug Application for AZ-004 in bartie 2010. Of the estimated 29.5 million migraine sufferers (including diagnosed and undiagnosed sufferers), there are at least two groups of potential patients for whom Alexza believes that AZ-104 could be effective and safe in comparison to pain treatmenttriptans, which are the most commonly used class of therapeutics for treating migraine. About Symphony Allegro In Alexza entered into a collaboration with Symphony Capital LLC, a biotech-focused private equity firm. In addition, according to the package inserts for triptans, they are contraindicated in patients with cardiovascular diseases, and should not be given to patients with risk factors for coronary artery disease (e.g., hypertension, high cholesterol, cigarette smoking). Safety evaluations will also be made throughout the clinical trial period. Such statements are subject to certain risks and uncertainties, online pharmaciesparticularly those inherent in the process of developing and commercializing drugs. Acute migraine headaches occur often, usually one to four times a month. AZ-104 met the primary efficacy endpoint of the clinical trial for the two highest doses epilator hair removalof the drug compared to placebo. If Alexza chooses not to exercise the purchase option, Symphony Allegro retains the rights to the product candidates. Safe Harbor Statement This includes forward-looking statements regarding the development, therapeutic potential, efficacy and safety of AZ-104. Alexza Initiates AZ-104 (Staccato(R) Loxapine) Phase tramadol2b Clinical Trial in Patients With Migraine Headaches MOUNTAIN VIEW, Calif., / - / -- Alexza Pharmaceuticals, Inc. ALXA) announced today that it has initiated a Phase 2b clinical trial with AZ-104 (Staccato loxapine) in patients with migraine headaches. Secondary efficacy endpoints for the trial include pain relief and other symptom assessments at various time points. "Failure or delay in commencing or completing clinical trials for our product candidates could harm our business", "If our product candidates do not meet safety and efficacy endpoints in clinical trials, they will not receive regulatory approval, and we will be unable to market them." and "We will need substantial additional capital in the future. "We previously announced atorvastatininitial results with AZ-104 in an in-clinic setting, showing its positive effect treating pain and other key symptoms of migraine headache," said pain reliefClaus B. Alexza has completed and announced positive initial results from both of its AZ-004 Phase 3 clinical trials, and is projecting a New Drug Application submission in clemmy 2010. Using the 4-point rating scale, the primary efficacy endpoint was pain-relief at 2 hours post-administration. Any statement describing a product candidate or Alexza's goals, expectations or beliefs is a forward-looking statement, as defined in the Private Securities Litigation Reform Act of 1995, and should be considered an at-risk statement. Product candidates that have completed Phase 1 testing are AZ-003 (Staccato fentanyl) for the treatment of breakthrough pain, which is partnered with Endo Pharmaceuticals in North America, and AZ-007 (Staccato zaleplon) for the treatment of insomnia. In addition, according drugstoreto the package inserts for triptans, they are contraindicated in patients with cardiovascular diseases, and should not be given to patients with risk factors for coronary artery disease (e.g., hypertension, high cholesterol, cigarette smoking). About Symphony Allegro In Alexza entered into a collaboration with Symphony Capital LLC, a biotech-focused private equity firm. The Staccato system technology is a hand-held, chemically-heated, single dose inhaler designed to generate and deliver excipient-free drug aerosol for deep lung delivery that results in IV-like pharmacokinetics. "Failure or delay in commencing or completing clinical trials for our product candidates prescription medicinescould harm our business", "If our product candidates do not meet safety and efficacy endpoints in clinical trials, they will not receive regulatory approval, and we will be unable to market them." and "We will need substantial additional capital in the future. More information, including this and past from Alexza, is available online at. Any statement describing a product candidate or Alexza's goals, expectations or beliefs is a forward-looking statement, as defined in the Private Securities Litigation prozac reviewsReform Act of 1995, and should be considered an at-risk statement. pain pillsSOURCE Alexza Pharmaceuticals, Inc.. Under the terms of the agreement, Alexza and Symphony Capital established Symphony Allegro, Inc., which is providing funding to Alexza to accelerate clinical and other related development activities of Staccato loxapine (AZ-004 and AZ-104) and Staccato alprazolam (AZ-002). The Company's technology, the Staccato system, vaporizes unformulated drug to form a condensation aerosol that allows rapid systemic drug delivery through deep lung inhalation. Secondary efficacy endpoints for the trial include pain relief and other symptom assessments at various time points. "We previously announced initial results with AZ-104 in an in-clinic setting, showing its positive effect treating pain and other key symptoms skin care machineof migraine headache," said tramadolHodge B. About Alexza Pharmaceuticals, Inc. King, Alexza President and CEO. Pain relief was observed in 76.7% of patients at the 5 mg dose (p 0.02), 79.1% of patients at the 2.5 mg dose (p 0.01) and 67.4% of patients at the 1.25 mg dose (p 0.18), compared to 51.3% of patients receiving placebo. AZ-104 was generally safe and well tolerated in this patient population. In the Company announced positive initial results of an in-clinic, multi-center, randomized, double-blind, single administration, placebo-controlled Phase 2a proof-of-concept clinical trial in 168 migraine patients online pharmacieswith or without aura. Alexza has five product candidates in clinical development. Alexza has completed and announced positive initial results from both of its AZ-004 Phase 3 clinical trials, and is projecting a New Drug Application submission in reese 2010. Alexza's lead program is AZ-004 (Staccato loxapine) that is being developed for the acute treatment of agitation in schizophrenic or bipolar disorder patients. The Company's forward-looking statements also involve assumptions that, if they prove incorrect, would cause its results to differ materially from those expressed pain medicationor implied by such forward-looking statements. AZ-104 is a lower-dose version of AZ-004 (Staccato loxapine), Alexza's lead product candidate that is in late Phase 3 clinical development for the acute treatment of agitation in patients with schizophrenia or bipolar disorder. 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. Through a purchase option, Alexza drugs online pharmacyretains the exclusive right, but not the obligation, to acquire 100% of the equity of Symphony online pharmacistAllegro at specified prices during the term of the agreement. Alexza Pharmaceuticals is an emerging specialty pharmaceutical company focused on the development and commercialization of novel, proprietary products for the treatment of acute and intermittent conditions. Three doses of AZ-104 (1.25, 2.5 and 5 mg) were evaluated against placebo in the clinical trial. Alexza has granted a license to certain intellectual property rights for the selected product candidates. AZ-104 met the primary efficacy endpoint of the clinical trial for the two highest doses of the drug compared to placebo. Many migraine sufferers who do take triptans have an insufficient therapeutic response to these medications. Safe Harbor Statement This includes forward-looking statements regarding the development, therapeutic potential, efficacy and safety of AZ-104. The primary efficacy endpoint for the trial is arthritisheadache pain relief at 2 hours post-dose, using the standard 4-point rating scale (International Headache Society). The AZ-104 Phase 2b clinical trial is an outpatient, multi-center, randomized, double-blind, single-dose, placebo-controlled study in approximately 360 patients who have migraines, with or without aura. Of the estimated 29.5 million migraine sufferers (including diagnosed and undiagnosed sufferers), there are at least two groups of potential patients for whom Alexza believes that AZ-104 could be effective and safe in comparison to triptans, which are the most commonly used class of therapeutics for treating migraine. The drug is quickly absorbed through the lungs into the bloodstream, providing speed of therapeutic onset that is comparable to intravenousprozac nation reviewstreatment pain pills xian mao supplement natural viagraadministration, but with greater ease, patient comfort and convenience. Alexza has five product candidates in clinical development. Alexza's lead program is AZ-004 (Staccato loxapine) that is being developed for the acute treatment of agitation in schizophrenic or bipolar disorder patients. If additional capital is not available, we will have to delay, reduce or cease operations". Many migraine sufferers who do take triptans have an insufficient therapeutic response to these medications. Product candidates that have completed Phase 1 testing are AZ-003 (Staccato fentanyl) for the treatment of breakthrough pain, which is partnered with Endo Pharmaceuticals in pain treatmentNorth America, and AZ-007 (Staccato zaleplon) for the treatment of insomnia. AZ-104 and AZ-004 are being developed through Symphony Allegro, a product development partnership formed between suki skin careAlexza and Symphony Capital, LLC. About Alexza Pharmaceuticals, Inc. About AZ-104 (Staccato loxapine) AZ-104 is the combination of Alexza's proprietary Staccato system with loxapine, a drug belonging to the class of compounds known as dopamine receptor antagonists. The primary efficacy endpoint for the trial is headache pain relief at 2 hours post-dose, using the pain medicationstandard 4-point rating scale (International Headache Society). Pain relief was observed in 76.7% of patients at the 5 mg dose (p 0.02), 79.1% of patients at the 2.5 mg dose (p 0.01) and 67.4% of patients at the do antibiotics help poison ivy1.25 mg dose (p 0.18), compared to 51.3% of patients receiving placebo. Three doses of AZ-104 (1.25, 2.5 and 5 mg) were evaluated against placebo in the clinical trial. Three doses will be evaluated in the clinical trial, placebo and two doses of AZ-104 (1.25 and 2.5 pain killersmg). The AZ-104 Phase 2b clinical trial is an outpatient, multi-center, randomized, double-blind, single-dose, placebo-controlled study in approximately 360 patients who have migraines, with or without aura. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of developing and commercializing drugs. SOURCE Alexza Pharmaceuticals, Inc. AZ-104 was generally safe and well tolerated in this patient population. AZ-104 is a lower-dose version of AZ-004 (Staccato loxapine), Alexza's lead product candidate that is in late Phase 3 clinical development for the acute treatment of agitation in patients with schizophrenia or bipolar disorder. The Company has completed an end-of-Phase 2 meeting with the FDA for AZ-001 (Staccato prochlorperazine), and it has advanced AZ-104 (Staccato loxapine) into Phase 2b testing, both product candidates being developed for the acute prescription drugs price comparisontreatment of migraine headache. These and other risks concerning Alexza's business are described in additional detail in the Company's Annual Report on Form 10-K for the year ended , and the Company's other Periodic and Current Reports filed with the Securities and Exchange Commission including the risks under the headings. Alexza has granted a license to certain intellectual property rights for the selected product candidates. If additional capital is not available, we will have to delay, reduce or cease operations". "We believe the potential value of the non-invasive nature and rapid onset of pharmacological action provided by our Staccato system is well-suited for migraine pain relief in the outpatient setting. More information, including this and past from Alexza, is available online at. Through a purchase option, Alexza retains the exclusive right, but not the obligation, to acquire 100% of the equity of Symphony Allegro at specified prices during the term of the agreement. The Company has previously announced positive results in two Phase 3 trials of AZ-004 and expects to submit a New Drug Application for AZ-004 in salvidor 2010. The Company has completed an end-of-Phase 2 meeting with the FDA for AZ-001 (Staccato prochlorperazine), and it has advanced AZ-104 (Staccato loxapine) into Phase 2b testing, both product candidates being developed for the acute treatment of migraine headache. Acute migraine headaches occur often, usually one to four times a month. King, Alexza President and CEO. Forward-looking statements contained in this announcement are made as of this date, and the Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. The Company's technology, the Staccato system, vaporizes unformulated drug to form a condensation aerosol that allows rapid systemic drug delivery through deep lung inhalation. In the Company announced positive initial results of an in-clinic, multi-center, randomized, double-blind, single administration, placebo-controlled Phase 2a proof-of-concept clinical trial in 168 migraine patients with or without aura. If Alexza chooses not to exercise the purchase option, Symphony Allegro retains the rights to the product candidates. Data from this outpatient clinical trial will guide our future development plans for AZ-104 for the treatment of migraine headaches." About Acute Migraine Headaches According to the National Headache Foundation, approximately 13 million people in the United States have been diagnosed with migraine headaches. The Company's forward-looking statements also involve assumptions that, if they prove incorrect, would cause its results to differ materially from those expressed or implied by such forward-looking statements. |
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