Zosano Announces FDA Submission of New Drug Application for Qtrypta
FREMONT, Calif., Dec. 23, 2019 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (Nasdaq:ZSAN), a clinical-stage biopharmaceutical company, today announced the submission of a 505(b)(2) New Drug Application (“NDA”) for Qtrypta™ to the U.S. Food and Drug Administration (“FDA”) for the acute treatment of migraine.
“Our NDA submission represents a significant milestone for Zosano and a culmination of our efforts to make Qtrypta available to patients who suffer from migraine. In clinical trials, Qtrypta demonstrated robust freedom from pain and most bothersome symptom, rapid and sustained pain relief, and was well tolerated,” said Steven Lo, president and chief executive officer of Zosano. “Qtrypta is the first NDA to be submitted to the FDA for a pharmaceutical microneedle application, and we look forward to working with the FDA during the review process. If successful, the approval would signal the validity of this product as a convenient, non-oral therapy for acute migraine sufferers, in addition to providing important validation of our delivery technology itself. We believe that Qtrypta, if approved, can make an important difference in the lives of patients who require acute treatment options for their migraine.”
Based on Zosano’s NDA submission on Friday, December 20, 2019, the company expects to receive notification from the FDA confirming whether the submission was accepted for filing for substantive review in March 2020.
The submission is supported by the results of the ZOTRIP pivotal Phase 2/3 clinical study, in which 41.5% of patients treated with the 3.8 mg dose of Qtrypta achieved pain freedom at 2 hours and 68.3% reported freedom from most bothersome symptom at 2 hours, both of which were co-primary endpoints. Additionally, 80.5% of patients reported pain relief at 2 hours, a secondary endpoint. The results of the study were published in Cephalalgia in October 2017.
A post-hoc analysis showing that Qtrypta reduced pain in subjects with difficult to treat migraines was published in Headache: The Journal of Head and Face Pain in February 2019.
Additionally, in the Phase 3 safety study, the most frequently reported adverse events were redness and swelling at the application site. Of these, 95% were reported as mild, and more than 80% resolved within 48 hours. Less than 2% of patients reported triptan-like neurological side effects typically found in the class, such as dizziness and paresthesia.
About Qtrypta™ (M207)
Qtrypta is Zosano’s proprietary formulation of zolmitriptan delivered utilizing its proprietary Adhesive Dermally-Applied Microarray (ADAM) technology. Zosano's ADAM technology consists of titanium microneedles coated with drug, and in the case of Qtrypta, its formulation of zolmitriptan. The drug-coated microneedles are designed to penetrate into the epidermis and dermis, where the investigational drug is dissolved and enters into the bloodstream. In February 2017, the company announced statistically significant results from the ZOTRIP pivotal study, in which the 3.8mg dose of Qtrypta met both co-primary endpoints, achieving pain freedom and most bothersome symptom freedom at 2 hours.
About Zosano Pharma
Zosano Pharma Corporation is a clinical stage biopharmaceutical company focused on developing products where rapid administration of molecules with demonstrated safety and efficacy profiles may provide substantial benefit to patients, in markets where patients remain underserved by existing therapies. The company’s ADAM technology consists of titanium microneedles coated with drug that can enable rapid systemic administration of therapeutics to patients. Zosano’s lead product candidate is Qtrypta (M207), which is a proprietary formulation of zolmitriptan delivered via ADAM technology, as an acute treatment for migraine. The company anticipates that many of its current and future development programs may enable the company to utilize a regulatory pathway that would streamline clinical development and accelerate the path towards commercialization. Learn more at www.zosanopharma.com.
This press release contains forward-looking statements regarding the expected acceptance for filing by the FDA of the New Drug Application for Qtrypta and the relating timing, the potential benefits of Qtrypta for patients and other future events and expectations. Readers are urged to consider statements that include the words "may," "will," "would," "could," "should," "might," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," "unaudited," "approximately" or the negative of those words or other comparable words to be uncertain and forward-looking. These statements are subject to risks and uncertainties that are difficult to predict, and actual outcomes may differ materially. These include risks and uncertainties, without limitation, associated with the NDA submission process, including that the information provided in the NDA will not be sufficient for the FDA to file and substantively review the application, the process of discovering, developing and commercializing products that are safe and effective for use as human therapeutics, risks inherent in the effort to build a business around such products and other risks and uncertainties described under the heading "Risk Factors" in the company's most recent quarterly report on Form 10-Q. Although Zosano believes that the expectations reflected in these forward-looking statements are reasonable, we cannot in any way guarantee that the future results, level of activity, performance or events and circumstances reflected in forward-looking statements will be achieved or occur. All forward-looking statements are based on information currently available to Zosano and Zosano assumes no obligation to update any such forward-looking statements.
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