Zosano Pharma Announces FDA Acceptance of 505(b)(2) New Drug Application for Qtrypta™ for the Acute Treatment of Migraine
The Prescription Drug User Fee Act goal date for the completion of the FDA’s review of Qtrypta™ is set for
“The FDA’s filing of our NDA represents a significant milestone and an important step for Zosano and Qtrypta toward our goal of bringing an innovative therapy that we believe can make an important difference in the lives of patients who suffer from migraine. We believe Qtrypta, if approved, has the potential to offer patients rapid, sustained pain relief with no recurrence,” said
“Migraine is a chronic and disabling neurological disease, affecting several areas of the brain and its blood vessels. Many patients are unsatisfied with their current acute treatment options. Migraine can significantly impair functional ability at work or school with devastating impact to the patient’s quality of life,” said
The NDA is supported by the clinical results of the ZOTRIP pivotal Phase 2/3 clinical study, which evaluated the efficacy, safety and tolerability of Qtrypta™ compared to placebo. A total of 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 also 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 migraine attacks was published in Headache: The Journal of Head and Face Pain in
Additionally, in the Phase 3 long term safety study, the most frequently reported adverse event was redness at the application site. Of these adverse events, 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 intracutaneous microneedle system (the “System”) in development for the acute treatment of migraine. The System consists of titanium microneedles coated with drug, and in the case of Qtrypta™, the formulation is zolmitriptan. The drug-coated microneedles are designed to penetrate the epidermis and dermis, where the investigational drug dissolves and easily enters into the bloodstream. In
Migraine is a highly prevalent neurological disease impacting 12% of the US population and 1 in 4 households. Patients impacted by migraine experience significant disability, with 90% unable to function normally. Migraine attacks are estimated to lead to lost productivity costs as high as
About Zosano Pharma
Zosano Pharma Corporation is a clinical-stage biopharmaceutical company focused on developing products where rapid administration of approved molecules with established safety and efficacy profiles may provide substantial benefit to patients, in markets where patients remain underserved by existing therapies. The company’s intracutaneous microneedle system technology consists of titanium microneedles coated with drug that are designed to 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 its intracutaneous microneedle system 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.
This press release contains forward-looking statements regarding the NDA for Qtrypta™ 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, 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.
Interim Chief Financial Officer
Source: Zosano Pharma Corporation