Alexza Announces Submission Of AZ-004 (Staccato(R) Loxapine) NDA
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Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) proclaimed that it has submitted its New Drug Application (NDA) for Staccato® loxitane (AZ-004) to the US Food and Drug Administration (FDA). AZ-004 is an aspiration merchandise campaigner existence highly-developed for the speedy intervention of turmoil in patients with schizophrenia or bipolar disarray . The IND for Staccato lox was filed with the FDA in August 2005.
“AZ-004 has delivered a predictable and uniform guard and efficaciousness visibility in treating patients with upheaval,” aforesaid James V. Cassella, PhD, Senior Vice President, Research and Development at Alexza. “We conceive that AZ-004, if sanctioned, has the voltage to alteration the intervention practices for knifelike ferment, as the sole production able-bodied to encounter both the patients’ trust for quick and well gaining ascendence, and the clinicians’ finish of quickly and dependably appeasement an agitated patient.”
“The information we suffer seen from the Staccato lox trials are compelling,” aforesaid Michael Lesem, MD, Executive Medical Director, Claghorn-Lesem Research Clinic, Houston, TX. “The intersection exhibits a speedy and predictable diminution in fermentation, and appears to bear a prosperous prophylactic visibility in these patient populations.”
“We erstwhile again exceeded our incorporated end timeline with the AZ-004 NDA meekness,” aforesaid Thomas B. King, President and CEO of Alexza. “The continued hard exertion of the full Alexza squad end-to-end 2009 has been cypher short-circuit of noteworthy and allowed us to over this watershed milepost for the society. We thirstily expression forward-moving to 2010, as we employment toward the approving of this intersection campaigner.”
“When Alexza was founded, I had the sight that its proprietorship engineering had the likely to ameliorate the curative rate of drugs,” aforesaid Alejandro C. Zaffaroni, PhD, Chairman Emeritus and Co-Founder of Alexza. “It is excellent that Alexza has reached its low NDA so rapidly and is on the threshold of its offset Staccato-based intersection, Staccato loxitane.”
The AZ-004 NDA contains efficaciousness and guard information from more than 1600 patients and subjects who get been studied in xiii dissimilar clinical trials. In 2008, the Company successfully initiated and realized two polar Phase 3 clinical trials. In these studies, both doses of AZ-004 (5 and 10 mg) met the basal and key junior-grade endpoints of the studies, with extremely statistically meaning reductions in excitement, as compared to placebo. Additionally, the 10 mg superman of AZ-004 exhibited a speedy attack of gist, with statistically important reductions in tempestuousness at 10 transactions post-dose, the offset clock head calculated. The step-down of fermentation was sustained done the 24-hour work menses. In both studies, the government of AZ-004 was broadly condom and swell tolerated.
In 2009, Alexza initiated and realized fin non-pivotal refuge and NDA-supporting studies for AZ-004. Alexza believes these information, on with information from the over-the-counter efficaciousness and guard trials conducted with AZ-004, adequately attest the efficaciousness and safe of AZ-004 for the proposed denotation.
Episodes of ferment smite many masses excruciation from major psychiatrical disorders, including schizophrenia, which affects around 2.4 billion adults in the United States, and bipolar distract, which affects some 5.7 meg adults in the United States. More than 90% of these patients bequeath get ferment in their life-time.
Agitation mostly escalates complete metre with patients initially notion uncomfortable, strain and uneasy. As the turmoil intensifies, their behaviour appears more obtrusive to others as they turn menacing and potentially trigger-happy, peculiarly if the tempestuousness is not hardened. While patients try discussion at unlike points on this turmoil continuum, those with the almost grievous symptoms loosely want intervention with injectable drugs in pinch aesculapian settings, and presently are intellection of to symbolise the excitement grocery. Alexza, notwithstanding, believes the alterative commercialise for hullabaloo is broader than lonesome this express position of patients in life-threatening crisis — many more are in indigence of discourse for an hullabaloo instalment.
Alexza’s master grocery search indicates that around 50% of toughened intense ferment episodes are hardened in exigency settings. Another around 35% of the toughened ferment episodes suffered by schizoid and bipolar patients are tempered in an inmate scene (infirmary and semipermanent residential settings), and roughly 15% are tempered in a doc’s place.
Alexza’s commercialise inquiry studies with schizophrenia patient caregivers and bipolar patients betoken these patients presently see an norm of 11 to 12 episodes of incisive excitement apiece year.
Agitation episodes are presently tempered most 55% of the clip with viva antipsychotics and approximately 45% of the meter with intra-muscular, or IM, injections. Oral medications study comparatively tardily, but are loose to allot, painless and are less minatory to patients. IM injections let a quicker oncoming of fulfill and a higher predictability of dose core, but because they are encroaching and can be awful to patients, IM injections are unremarkably the discussion selection of last-resort. Currently, no non-invasive therapies are usable that ferment quicker than 30 proceedings to assistance agitated patients in pauperism of handling.
AZ-004 is an anti-agitation alterative that combines Alexza’s proprietorship Staccato organization with lox, a dose belonging to the family of compounds known loosely as antipsychotics. Loxapine is presently usable in an viva conceptualisation in the United States for the direction of the manifestations of schizophrenia. The Staccato organisation is a handheld, chemically-heated, single-dose inhalator that delivers a complete dose aerosol to the extremely vascularized tissues of the abstruse lung.
As an easy-to-use, patient-controlled, and extremely honest cure that provides speedy decrease in turmoil, the Company believes that AZ-004 meets the tercet key attributes for the discussion of keen hullabaloo as specified in the American Association of Emergency Psychiatrists’ Expert Consensus Guidelines for the Treatment of Behavioral Emergencies: swiftness of oncoming, dependableness of medicine rescue and patient predilection.
Alexza Pharmaceuticals is a pharmaceutic fellowship focussed on the inquiry, growth and commercialisation of new, proprietorship products for the penetrating discussion of exchange queasy arrangement weather. Alexza’s engineering, the Staccato scheme, vaporizes unformulated dose to manikin a condensate aerosol that, when inhaled, allows for speedy systemic dose livery done rich lung inhalant. The dose is chop-chop enwrapped done the lungs into the bloodstream, providing amphetamine of sanative onslaught that is like to endovenous judicature, but with greater simpleness, patient solace and gismo.
AZ-004 (Staccato lox) is Alexza’s leading platform, which is existence highly-developed for the speedy intervention of excitement in schizoid or bipolar disorderliness patients. Alexza has realised and proclaimed cocksure results from both of its AZ-004 Phase 3 clinical trials, and submitted a New Drug Application compliance in December 2009.
Alexza has realized an end-of-Phase 2 confluence with the FDA for AZ-001 (Staccato prochlorperazine ) and has realised two Phase 2 studies with AZ-104 (Staccato lox, low-dose). Both intersection candidates are beingness highly-developed for the ague discussion of hemicrania worry .
AZ-002 (Staccato xanax) has realised Phase 1 examination and one Phase 2a proof-of-concept clinical tryout. Product candidates that suffer accomplished Phase 1 examination are AZ-003 (Staccato fentanyl) for the discourse of find bother, and AZ-007 (Staccato zaleplon) for the discourse of insomnia .
This imperativeness waiver includes innovative statements regarding the exploitation, healing voltage and condom of AZ-004. Any instruction describing a merchandise prospect or Alexza’s goals, expectations or beliefs is a advanced argument, as outlined in the Private Securities Litigation Reform Act of 1995, and should be considered an at-risk command. Such statements are issue to sealed risks and uncertainties, especially those underlying in the treat of underdeveloped and commercializing drugs. Alexza’s modern statements besides necessitate assumptions that, if they evidence wrong, would case its results to dissent materially from those verbalised or implied by such innovative statements. These and otc risks concerning Alexza’s byplay are described in extra contingent in Alexza’s Annual Report on Form 10-K for the year over December 31, 2008, and Alexza’s early Periodic and Current Reports filed with the Securities and Exchange Commission, including the risks nether the headings: “We leave indigence substantive extra majuscule in the next. If extra great is not useable, we leave suffer to retard, tighten or milliliter operations.”, “Regulatory regime may not sanction our production candidates tied if they fulfil rubber and efficaciousness endpoints in clinical trials.” and “If we do not ground strategical partnerships, we volition get to tackle growth and commercialisation efforts on our own, which would be pricy and holdup our power to market any next products”. Forward-looking statements contained in this promulgation are made as of this escort, and we contract no duty to publically update any advanced assertion, whether as a termination of new data, next events or differently .
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