Ubrogepant

AbbVie lost about $40 billion in market value Monday morning after an experimental drug the company had bet heavily on failed two important clinical trials.The drug, called emraclidine, was developed by Pfizer spinout Cerevel Therapeutics, which AbbVie recently acquired for almost $9 billion. Its one of a new class of brain-balancing medications researchers see as valuable tools for treating a variety of psychiatric conditions. With emraclidine, Cerevel chose schizophrenia as the first target, and over the past couple of years has been running a pair of studies to assess whether the drug can quickly alleviate symptoms of the disorder.AbbVie has now disclosed the studies did not succeed. Three doses of the drug were tested, and neither performed significantly better than a placebo after six weeks of treatment. The trials together enrolled around 750 participants, and evaluated them with a well-known scale used to measure the different symptoms people with schizophrenia experience, from positive ones like excitement and hallucinations to negative ones like emotional withdrawal.“While we are disappointed with the results, we are continuing to analyze the data to determine next steps,“ said Roopal Thakkar, AbbVies chief scientific officer,in the companys statement.The Illinois-based pharmaceutical giant said neuroscience remains one of its key focus areas. Just last month, AbbVie announced plans to spend $1.4 billion buying a startup with an experimental treatment for Alzheimers disease.The company also noted how it gained an entire pipeline of drug programs from the Cerevel acquisition, with multiple clinical-stage and preclinical candidates that complement its existing portfolio of brain medicines. Net revenue from that portfolio, which includes Botox, the antipsychotic Vraylar and the migraine medication Ubrelvy, totaled almost $6.5 billion over the first nine months of this year.One such Cerevel drug, a Parkinsons treatment called tavapadon, defied analyst expectations by succeeding in a late-stage trial earlier this year.Still, AbbVie investors may not see much of a silver lining. Company shares were down more than 12% Monday morning, representing one of the largest single-day dips involving a big pharma stock over the past year.This is disappointing and unexpected, wrote Louise Chen, an analyst at the investment firm Cantor Fitzgerald, in a note to clients.In an earlier, much smaller schizophrenia trial, researchers found two doses of emraclidine each beat a placebo at reducing scores on the same symptoms scale used in the Phase 2 studies.Additionally, emraclidine works in a similar way to Cobenfy, an antipsychotic medication that succeeded in three medium- to large-sized clinical trials before receiving Food and Drug Administration approval in September. Less than three weeks after AbbVie announced its Cerevel acquisition, Bristol Myers Squibb agreed to buy Cobenfys developer, Karuna Therapeutics, for $14 billion.Schizophrenia patients switch medications often, either because they carry side effects like weight gain or because they arent properly controlling the disease. Clinical testing of Cobenfy showed it doesnt cause some of the more challenging side effects seen with other antipsychotics. That, plus Cobenfys ability to act quickly, has led both Bristol Myers and Wall Street analysts to expect billions of dollars in peak annual sales from the drug.Shares of Bristol Myers were up almost 12% late Monday morning.Olivia Brayer, an analyst at Cantor who covers the company, argues that emraclidines failure removes a major overhang for Cobenfy, as its biggest competitive threat in schizophrenia is no longer.The Cerevel acquisition just went up in flames, Brayer wrote in a note to clients, adding that her team has been getting questions about how Bristol Myers stock could move based on the results of AbbVies two studies. But an outright failure wasn't on anyone's bingo card. '

A meta-analysis of 137 trials of migraine drugs indicates that the newest class of treatments are less effective than the previous generation of triptan drugs in relieving acute headaches. A study from The BMJ indicates that the newest class of migraine drugs—which includes Pfizer’s Nurtec, AbbVie’s Ubrelvy and Eli Lilly’s Reyvow—is less effective in the acute treatment of migraines than a previous class of medicines.What's more, the newer drugs are no more effective in treating migraines than traditional headache remedies such as Tylenol, ibubrofen and aspirin, according to The BMJ's analysis.The study, a meta-analysis of 137 trials that together enrolled nearly 90,000 patients, indicates that the most effective treatments for migraine come from the triptan class. In head-to-head comparisons of the 17 drugs covered in the study, triptans demonstrated the best efficacy within 2 hours of use, led by eletriptan, which also delivered the best-sustained relief over 24 and 48 hours, according to the analysis.Eletriptan was brought to the market by Pfizer in 2002 and sold under the brand name Relpax. The next most effective medicines in providing relief at 2 hours were the following triptans (in order of performance): rizatriptan, sumatriptan and zolmitriptan. Rizatriptan is sold by Organon as Maxalt. GSK sells sumatriptan as Imitrex and AstraZeneca markets zolmitriptan as Zomig.“Triptans are currently widely underused, and access to the most effective triptans should be promoted globally and international guidelines updated accordingly,” the authors wrote. The BMJ analysis also concluded that the newest class of migraine treatments—which are called calcitonin gene-related peptide receptor (CGRP) antagonists—should only be used after traditional headache meds.“While the recent introduction of lasmiditan (Reyvow), rimegepant (Nurtec), and ubrogepant (Ubrelvy) has expanded options for the acute treatment of migraine, the high cost of these newer drugs, along with the substantial adverse effects of lasmiditan, suggest their use as third-line options, after the less expensive, similarly efficacious, second-line options," the authors wrote.While the BMJ study focused on acute treatment of migraines, new CGRP treatments have also been approved as preventatives. Nurtec pills, for example, were approved in 2021 for use every other day to ward off potential migraines. Much hope has been pinned on the effectiveness of CGRP drugs. In 2022, Pfizer spent $11.6 billion in a buyout of Biohaven to gain Nurtec, which rolled up sales of $928 million last year. Meanwhile, Ubrelvy, which was approved in 2019, generated $815 million in sales.Several other CGRPs—all approved in 2018 for the prevention of migraines—also remain formidable. Eli Lilly’s Emgality generated $678 million in sales last year, while Teva’s Ajovy pulled in $435 million and Amgen’s Aimovig collected $303 million. Besides those drugs, Lundbeck's Vyepti won approval in 2020 and generated about $250 million last year.