Axsome to narrow focus of depression drug trial after limited success in initial run
April 1 (Reuters) - Axsome Therapeutics (AXSM.O), opens new tab said on Tuesday it will narrow the focus of a late-stage study of its depression drug after an initial run of the trial showed improvement only in a small subgroup of patients.
The drug, solriamfetol, did not show statistically significant improvement in the overall group of patients.
Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here.
However, it helped reduce symptoms in some patients with major depressive disorder who also suffered from excessive daytime sleepiness (EDS), a common symptom of MDD.
"The study missing in the overall MDD population limits the market opportunity significantly, and is disappointing given the company's expertise in the space," RBC Capital Markets analyst Leonid Timashev said in a client note.
Axsome said it plans to start a larger late-stage study of the drug in MDD patients with EDS this year.
The initial late-stage study that served as a proof of concept for the larger trial had enrolled 346 participants with MDD, of which 51 patients had severe EDS, the company said.
The drug was well-tolerated in the study with no new safety concerns, Axsome said.
Each year, around 21 million adults in the U.S. are affected by MDD, according to the company.
Solriamfetol has already been approved in the U.S. to improve wakefulness in adults with excessive sleepiness from sleep disorders, narcolepsy and sleep apnea, and is sold under the brand Sunosi.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Reuters
7 hours ago
- Reuters
Magnitude 6.5 earthquake strikes Colombia, GFZ says
June 8 (Reuters) - A magnitude 6.5 earthquake struck Columbia on Sunday, the German Research Centre for Geosciences (GFZ) said. The quake was at a depth of 10 km (6.21 miles), GPZ said.
Reuters
2 days ago
- Reuters
Novo's Ozempic, Wegovy linked to rare cases of dangerous eye disorder, EMA says
June 6 (Reuters) - The European Medicines Agency's safety committee has concluded that the use of Novo Nordisk's ( opens new tab popular weight-loss drug Wegovy and its treatments for type 2 diabetes may cause rare occurrences of a potentially dangerous eye condition. Called non-arteritic anterior ischemic optic neuropathy (NAION), the condition may affect up to 1 in 10,000 people taking semaglutide, the active ingredient in Wegovy and Novo's diabetes drugs Ozempic and Rybelsus, the regulator said on Friday. The EMA, which started its review in December, said the use of the drugs is linked to about twofold increase in the risk of developing the condition compared to people not taking the medicine. NAION develops from insufficient blood flow to the optic nerve and causes sudden painless vision loss in one eye. It is the second most common cause of blindness due to optic nerve damage, after glaucoma. Studies have linked semaglutide to NAION in the past. But this is the first time a regulator has made the link. Semaglutide belongs to a class of drugs known as GLP-1 receptor agonists, which work by helping control blood sugar levels and triggering a feeling of fullness. A large study of nearly 350,000 diabetics published earlier this year had showed that the risk of developing NAION more than doubled after long-term use of semaglutide, compared to patients taking medicines from other classes. The EMA said it has reviewed all available data on NAION with semaglutide, including data from non-clinical studies, clinical trials and post-marketing surveillance. It has recommended the drugmaker to update prescribing information for medicines containing semaglutide to include NAION as a side effect with a frequency of "very rare". The U.S. Food and Drug Administration did not immediately respond to a Reuters request for comment.
Reuters
2 days ago
- Reuters
Health Rounds: Roche's Tecentriq reduces recurrence, deaths for certain colon cancer patients
June 6 (Reuters) - (This is an excerpt of the Health Rounds newsletter, where we present latest medical studies on Tuesdays and Thursdays. To receive the full newsletter in your inbox for free sign up here.) Adding Roche's (ROG.S), opens new tab immunotherapy drug Tecentriq to chemotherapy after surgery in certain patients whose colon cancer had spread to the lymph nodes led to a 50% reduction in cancer recurrence and death compared to chemotherapy alone, according to trial data presented at recent medical meeting. Patients in the study had tumors with a genetic defect known as deficient DNA mismatch repair, or dMMR. About 15% of colon cancer patients have dMMR tumors, which do not respond well to chemotherapy. "The findings from our study represent a major advance in the adjuvant treatment of dMMR stage 3 colon cancer and will now change the treatment for this type of cancer," study leader Dr. Frank Sinicrope of the Mayo Clinic in Rochester, Minnesota said in a statement. The data, opens new tab were presented at the ASCO meeting that concluded earlier this week. The trial enrolled 712 patients with dMMR stage 3 colon cancer that had been surgically removed and who had cancer cells in their lymph nodes. Half of the study participants received chemotherapy along with Tecentriq, which activates the immune system to attack and kill cancer cells, for six months, followed by the immunotherapy alone for another six months. The other half of the patients received chemotherapy for 12 months. The benefit of Tecentriq was seen even in the oldest patients and those at particularly high-risk. "It's extremely rewarding to be able to offer our patients a new treatment regimen that can reduce the risk of recurrence and improve their chances of survival," Sinicrope said. As patients recover after a minimally invasive heart procedure, they might be better off continuing to take a certain type of blood-thinning drug to help prevent a heart attack or stroke, instead of continuing with the traditional aspirin, a new study suggests. Early after percutaneous coronary intervention (PCI) - a procedure to prop open blocked arteries either after a heart attack, or to prevent one - patients often receive dual anti-clotting therapy with both a P2Y12 inhibitor such as clopidogrel, the generic version of Plavix, or AstraZeneca's (AZN.L), opens new tab Brilinta (ticagrelor), and aspirin. After several months, patients are usually switched from dual therapy to lifelong daily aspirin use. But pooled data looking at patients who took part in five earlier clinical trials found that continuing to prescribe the P2Y12 inhibitors and stopping the aspirin was associated with lower rates of death, heart attack and stroke compared with continuing the aspirin, with no increased risk of major bleeding, researchers reported in The BMJ, opens new tab. Overall, the trials involved 16,117 patients who received either a P2Y12 inhibitor or aspirin after completing dual therapy following PCI. After an average follow-up period of around 4 years, P2Y12 inhibitor therapy was associated with a 23% lower risk of a composite of heart-related death, heart attack, or stroke, compared with aspirin, with no significant difference in major bleeding. That translates into one prevented cardiovascular death, heart attack, or stroke for every 46 patients taking a P2Y12 inhibitor instead of aspirin after dual therapy. Overall, the findings suggest that P2Y12 inhibitor drugs should be preferred over aspirin 'due to reductions in major adverse cardiac and cerebrovascular events without increasing major bleeding in the medium term,' according to an editorial published with the study. But the editorial said that since patients are advised to continue the post-PCI therapy for life, large trials directly comparing the different strategies with longer follow up are needed. Some diabetes and weight-loss drugs from the class known as GLP-1 agonists were linked with a small but elevated risk for an age-related eye disease in patients with diabetes, according to a study published on Thursday in JAMA Ophthalmology, opens new tab. In 139,000 patients with diabetes, including 46,334 who had been using the GLP-1 drugs semaglutide or lixisenatide, researchers identified 181 new cases of neovascular age-related macular degeneration, also known as wet AMD. Wet AMD is a degenerative eye disease marked by the abnormal growth of blood vessels under the retina that leak fluid or blood and can lead to blindness. The risk of developing AMD during up to three years of follow-up was low, at 0.2% in GLP-1 users versus 0.1% in non-users. Still, the researchers point out, after accounting for patients' individual risk factors, the odds of AMD were doubled with at least six months of GLP-1 use and tripled in patients with the longest duration of use. Semaglutide is the active ingredient in the widely used Novo Nordisk ( opens new tab drugs Ozempic and Wegovy, while lixisenatide is the main ingredient in Sanofi's ( opens new tab discontinued Adlyxin. GLP-1 drugs have also been associated with higher risks for an eye condition known as nonarteritic anterior ischemic optic neuropathy, or NAION. Researchers did not have information about the dose, route of administration, or frequency of administration of the medications used in the study. Even with that information, the study could not have proved cause and effect. At least one earlier study with longer follow up reported that GLP-1 use was linked with a lower, rather than higher, risk for AMD. 'Our findings are not directly contradictory' with that earlier report, said study leader Dr. Reut Shor of the University of Toronto. 'Factors such as timing and duration of exposure, disease stage, and patient characteristics may all influence outcomes," Shor said. "Our results add another layer to the emerging understanding of this complex relationship and emphasize the need for further research to clarify these trends.' (To receive the full newsletter in your inbox for free sign up here)
