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Zosano gets Crucial FDA Nod for New Drug Application for Qtrypta™ for Acute Treatment of Migraine

06 Mar Zosano gets Crucial FDA Nod for New Drug Application for Qtrypta™ for Acute Treatment of Migraine

Zosano Pharma (NASDAQ: ZSAN), a clinical-stage biopharmaceutical Company, announced the acceptance of the Company’s New Drug Application for Qtrypta™, a proprietary formulation of Zolmitriptan by the U.S Food and Drug Administration (FDA) for filing and substantive review. The FDA has set a The Prescription Drug User Fee Act goal date of October 20, 2020.

The Company filed the NDA on the basis of the results from its crucial Phase 2/3 clinical namely ZOTRIP, which demonstrated that 41.5% of the patients treated with Qtrypta™ experienced freedom from pain at 2 hours after administration of a 3.8 mg dose, while 68.3%of the patients felt relieved of the most bothersome symptoms at 2 hours. These constituted the primary endpoint of the study, while pain relief at 2 hours was the secondary endpoint.

Steven Lo, President and Chief Executive Officer of Zosano, commented,

“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”. He further added, “This submission also represents the first NDA to be submitted to the FDA for a pharmaceutical microneedle patch. We believe this technology, if approved, has the potential to transform how drugs, biologics and vaccines are delivered, and we look forward to further discussions with the FDA during its review of this submission. We are grateful for the patients who participated in our clinical trials, our clinical investigators and the entire Zosano team who have helped us realize this significant milestone.”

Zosano also reported that the most frequently reported adverse event was redness at the application site, of which 95 percent were mild, and more than 80 percent resolved within 48 hours. 2 percent of patients experienced neurological side effects such as dizziness and paresthesia, which is not uncommon in these class of drugs.

Zosano Pharma Corporation (NASDAQ: ZSAN)

Market Cap: $19.17M; Current Share Price: 0.7755 USDChart
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Migraine is a genetic predisposition to moderate-to-severe headaches caused due to stress, physiological factors such as lack of sleep, hunger and environmental triggers such as sensitivity to lights and sounds or hormonal changes in case of women. It manifests in the form of throbbing pain in the head, nausea, photophobia, excessive sweating etc. The International Classification of Headache Disorders system gives a differentiation between various kinds of migraines and headaches for easy diagnosis and treatment.

It is considered to be the third most prevalent disease in the world, affecting over 37 million in the U.S alone. It costs over $36 billion in lost productivity and incurs an estimated $5.4 billion in treatment costs. A report by Grand View Research predicts that the Global Migraine Therapeutics market will be worth over USD 7.8 billion by 2025 growing at a CAGR of 18.0%.

The current treatment options for migraine consist of generic triptans and other off-label drugs that have adverse side effects and are by and large ineffective. These come with side-effects such as drowsiness, memory related issues and weight gain.

However the increased research and development efforts and spending in this field, coupled with use of scientific advancements has given rise to novel treatment solutions such as CGRP-based therapies, 5-HT1F receptor agonistshistamine and H1 receptor antagonists to name a few.

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Zosano’s ADAM (Adhesive Dermally Applied Microarray), is a small adhesive device for intracutaneous drug delivery, that helps in the rapid absorption of drugs and comes with a low cost reusable handheld applicator. It is a row of thousands of micro titanium projections, mounted on a backing that resembles an adhesive bandage, which penetrates the epidermis (stratum corneum) upon application and mixes with interstitial fluid in the skin enabling rapid absorption. Each patch contains 340μm sized micro needles that can accommodate both large and small molecules.

The intracutaneous patch enables rapid absorption of drugs into the capillary bed. QtryptaTM (M207), a small molecule 5HT3 inhibitor, is the company’s lead drug program indicated for the treatment of Acute Migraine. The candidate offers rapid and sustainable effect with just one dose and its action lasts through 48 hours. Most importantly it provides a much needed oral treatment option for patients who suffer from nausea and vomiting.

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ADAM offers numerous advantages over conventional drug delivery options by doing away with the need for a hypodermic needle for rapid parenteral delivery. In case of drugs with poor oral bioavailability or severe nausea making it difficult to retain ingested medication, this technology comes as a boon. In clinical studies it has demonstrated 3-times faster absorption of zolmitriptan when compared with oral administration.

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The Company reported cash and cash equivalents of and marketable securities were $6.5 million, compared with $23.0 million as of December 31, 2018.

Risk Assessment 

  • Zosano’s highly differentiated Patch Technology has the potential to be a game-changer in novel application of proteins, peptides and vaccines. The technology is the first and only microneedle patch to be included in an FDA submission till date.
  • The Company intends to initiate a phase 2/3 clinical study in 2020, for acute treatment of cluster headaches, which affects over 300,000 people in the U.S. This offers a great opportunity for clinical development as the last FDA approved treatment for this indication was in 1990’s.
  • Zosano is focused on developing a diverse pipeline of candidates such as small molecules, hormones, peptides and proteins and a prophylactic vaccine. Furthermore the Company intends to explore the potential application of this technology in cancer vaccines, immune-modulation/immune-therapy, local/systemic delivery applications and other novel compounds.
  • The Company is helmed by an experienced management team who has extensive experience in clinical development, sales, marketing, operations and regulatory matters. This will help the Company navigate through regulatory uncertainties and the unpredictable nature of clinical trials.
  • Zosano has already initiated pre-commercial activities such as targeting, market research, sales force resizing and distribution strategy, in anticipation of a commercial launch.
  • Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

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