US Neurologists Cautiously Optimistic About Potential Approval of Pfizer's Zavegepant for the Acute Treatment of Migraine, According to Spherix Global Insights

2023-02-28

临床结果

Recently released positive phase 3 data for Pfizer's zavegepant likely to fuel already noted perceptions among prescribers that the brand will have a high responder rate. On February 16, The Lancet Neurology published the Phase 3 results of Pfizer's zavegepant for the acute treatment of migraine. The CGRP receptor antagonist nasal spray has met its co-primary endpoints that a single 10mg dose proved to be more effective than placebo for both pain freedom and freedom from the most bothersome symptom (MBS) at two-hours post-dose. Zavegepant provided relief from migraine pain in 15 minutes, lasting up to 48 hours, according to the release. Due to these promising results, zavegepant is expected to receive FDA approval for the acute treatment of migraine in early 2023. Pre-launch assessments of zavegepant, collected from a sample of 100 specialists, indicate that Pfizer's asset will be met with some cautious optimism. Specifically, respondents viewed zavegepant as a moderate advancement over other agents in this space, including Impel's Trudhesa, due to its preferred dosing formulation and anticipated responder rate. Trudhesa, the most recent acute treatment among migraine market entrants, is similar to zavegepant as both are nasal sprays, providing relief in as fast as 15 minutes with one dose and potentially allowing for up to two pain-free days. Though both products are administered intranasally, a major difference between the agents is that Trudhesa is a DHE (dihydroergotamine) while zavegepant is an anti-CGRP, similar to the more proven products, Pfizer's Nurtec ODT and AbbVie's Ubrelvy. Spherix is nearing completion of launch tracking of Trudhesa for its first 18 months of commercial availability. Results from the most recent Trudhesa deep dive launch assessment – fielded in December 2022 - reveal that uptake can be slow-to-moderate for a newly branded product entering this space. Nurtec ODT, a recent Pfizer purchase and available for the acute treatment of migraine since February 2020 and AbbVie's Ubrelvy, available since December 2019, show the highest physician-reported branded market share, while share of Trudhesa and Eli Lilly's Reyvow – on the market since October 2019 – account for just a fraction of use in comparison. Fortunately for Pfizer, zavegepant is expected to be available ahead of several other products currently in the pipeline for the acute treatment of migraine. Phase 3 products include Axsome's AXS-07, an oral anti-CGRP with FDA approval expected late 2023; Amneal's DHE autoinjector, expected to be submitted for approval in Q4 2023; and Satsuma's STS-101, a DHE product that would be the first powder nasal spray as opposed to liquid or injection. Once commercially available, Spherix Global Insights will probe U.S. neurologists and migraine specialists as part of its' monthly market tracking. Launch Dynamix™ service, which will continue for zavegepant's first eighteen months on the market. The service will also include a quarterly deep dive into reported patient share, brand perceptions, patient initiations/discontinuations, and drivers and barriers of prescribing. Since 2018, Spherix Global Insights has tracked the migraine market and will continue coverage of this ever-growing space. Uptake and impact of zavegepant will be closely monitored via the

Launch Dynamix™ service, while

RealTime Dynamix™ covers overall in-line use, perceptions, pipeline awareness and intent, and perceptions of acute and preventive treatments. New start and switching patient segments will be explored via

RealWorld Dynamix™ services, including drivers of brand choice, treatment by acute and preventive products and severity levels, and potential next switches.

About Launch Dynamix™ Launch Dynamix™ is an independent service providing monthly benchmarking of newly launched products for the first eighteen months of commercial availability, augmented by a quarterly deep dive into promotional activity, barriers to uptake, and patient types gravitating to the launch brand.

About RealTime Dynamix™ RealTime Dynamix™ is an independent service providing strategic guidance through quarterly or semiannual reports, which include market trending and a fresh infusion of event-driven and variable content with each wave. The reports provide an unbiased view of the competitive landscape within rapidly evolving specialty markets, fueled by robust HCP primary research and our in-house team of experts.

About RealWorld Dynamix™ RealWorld Dynamix™ is an independent, data-driven service unveiling real patient management patterns through rigorous analysis of large-scale patient chart audits. Insights reveal the "why" behind treatment decisions, include year over year trending to quantify key aspects of market evolution, and integrate specialists' attitudinal & demographic data to highlight differences between stated and actual treatment patterns.

About Spherix Global Insights Spherix Global Insights is a leading provider of market research, business intelligence and advisory services to the global life sciences industry. The company's unique service offerings are powered by deep therapeutic knowledge, the Spherix Network specialty physician panel, and commercially relevant analyses to enable strategic decision-making by our valued customers. A trusted advisor and industry thought leader, Spherix Global Insights provides specialized market expertise in six (6) focused therapeutic areas including: dermatology, gastroenterology, nephrology, neurology, rheumatology and ophthalmology.

SOURCE Spherix Global Insights

机构

Axsome Malta Ltd.