Pfizer's zavzpret nasal spray gains approval for treatment of migraine
Pfizer makes a breakthrough in migraine treatment with the approval from the US FDA of its new drug Zavzpret™ (zavegepant) in the form of a nasal spray, which adds to their current portfolio of oral migraine prevention and treatment therapies.
Zavzpret is a calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray, the first of its kind for the treatment of migraine in adults.
The nasal spray was tested in a Phase III clinical trial on patients with migraines with or without auras, and compared to a placebo. The primary end points of the study were taken as freedom from pain and freedom from most bothersome symptoms when measured 2 hours after the provision of the dose. According to monitoring for a secondary end point, pain relief was logged even as quickly as 15 minutes after dosing.
“The FDA approval of zavzpret marks a significant breakthrough for people with migraine who need freedom from pain and prefer alternative options to oral medications,” explained Angela Hwang, Chief Commercial Officer, President, Global Biopharmaceuticals Business, Pfizer. “Zavzpret underscores Pfizer’s commitment to delivering an additional treatment option to help people with migraine gain relief and get back to their daily lives. Pfizer will continue to build its migraine franchise to further support the billions of people worldwide impacted by this debilitating disease.”
The nasal spray has been rigorously tested in randomized, double-blind, placebo-controlled trials to determine the efficacy, tolerability and safety of zavzpret. In all of these studies, zavzpret demonstrated significantly better outcomes than when compared to a placebo. In the most recent Phase III trial, the results of which were published in The Lancet Neurology, zavzpret showed significantly greater efficacy than the placebo in 13 out of 17 predetermined secondary endpoints. These included time to pian relief and time to normal function as 15–30 minutes and 30 minutes respectively. Other end points also measured were sustained pain freedom and relief after 2–24 hours and 2–48 hours.
“When a migraine hits, it has a significant negative impact on a person’s daily life,” commented Kathleen Mullin, Associate Medical Director at New England Institute for Neurology & Headache. “Among my migraine patients, one of the most important attributes of an acute treatment option is how quickly it works. As a nasal spray with rapid drug absorption, zavzpret offers an alternative treatment option for people who need pain relief or cannot take oral medications due to nausea or vomiting, so they can get back to normal function quickly.”
The safety of the nasal spray was tested, and minor adverse reactions were observed. The most common of which, – taste disorders (includes dysgeusia and ageusia), nausea, nasal discomfort, and vomiting – were seen in around 2% of patients. Hypersensitivity reactions have also occurred in trials involving zavzpret.
The results were analysed by the US FDA and the spray was deemed worthy of approval. Pfizer hopes zavzpret will be available to patients from pharmacies by July 2023.
Related News
-
News On Track at Pharmapack 2024 - The Track Sponsor interview: BD Pharmaceuticals
January 2024 brings both a new year and Europe’s leading packaging and drug delivery event. Bringing the world’s experts in pharmaceutical packaging together in Paris, France, Pharmapack 2024 brings exciting opportunities to learn and colla... -
News Patients vs Pharma – who will the Inflation Reduction Act affect the most?
The Inflation Reduction Act brought in by the Biden administration in 2022 aims to give better and more equitable access to healthcare in the USA. However, pharma companies are now concerned about the other potential costs of such legislation. -
News Roche breaks into the obesity drug market with the acquisition of Carmot Therapeutics
In a bid to diversify their therapeutic offerings, Roche takes over Carmot Therapeutics in $2.7 billion deal, with one obesity drug spearheading the venture into the field as they prep for a Phase II in-human trial. -
News Biden backs Cold-War measures to shore-up medical supply chains
In a recent strategy to combat rising inflation and the cost of living crisis, President Joe Biden has invoked a Cold War-era act to increase investment in a selection of medicines and supplies. -
News Women in Pharma: Delivering solutions for gender diversity
In our new monthly series, we interview women from across the pharmaceutical industry and supply chain to discuss the importance of gender diversity in healthcare, the workplace, and beyond. -
News CPHI Barcelona Speaker Interview – What the US FDA’s Quality Management Maturity Means for the Pharma Industry
At CPHI Barcelona (24–26 October, 2023), we spoke to Sireesha Yadlapalli, CEO of Pharmatech Associates, who gave a presentation on the implications of the US FDA’s Quality Management Maturity (QMM) Initiative, and spoke on the panel of the ... -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News Wegovy and weight-loss drugs driving demand for manufacturers that can fill syringes
Injectable weight-loss treatments are prompting contract manufacturers to invest and include fill-finish services into their service portfolios, in a bid to attract pharmaceutical giants developing drugs similar to Novo Nordisk's Wegovy.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance