I am going to develop a placebo migraine drug and charge it at 5% of whatever Amgen prices its migraine drug. Look at how high the placebo effect is. From a relative perspective, Amgen is 60% better than placebo. Since their is a high placebo effect, my placebo drug will be 5% of Amgen's price. So it will be 12.5X or 12,500% more cost effective than Amgen's drug based on price. I win! Amgen Presents Positive Data At EHMTIC 2016 Demonstrating Erenumab Significantly Reduces Monthly Migraine Days In Patients With Chronic Migraine THOUSAND OAKS, Calif., Sept. 15, 2016 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced detailed global Phase 2 results showing erenumab demonstrated a statistically significant reduction in monthly migraine days compared with placebo in patients with chronic migraine. The data will be presented in posters #P057 and #P058 at the 5th European Headache and Migraine Trust International Congress (EHMTIC) in Glasgow, Scotland. "Chronic migraine patients lose more than half of their life to migraines with 15 or more headache days a month, facing intolerable pain and physical impairment," said Stewart Tepper, M.D., professor of neurology at the Geisel School of Medicine atDartmouth. "As a neurologist, these findings are exciting because they demonstrate that erenumab could serve as an important new therapy option for reducing the burden of this often-disabling disease." The study included 667 patients (mean age 42.1, 79.0 percent female) who were randomized to receive either subcutaneous placebo (n=286) or subcutaneous erenumab 70 mg (n=191) or 140 mg (n=190) once a month. Patients had a mean baseline of 18.0 migraine days per month and a mean baseline of 21.1 headache days per month. Patients randomized to both erenumab dose groups experienced a statistically significant 6.6-day reduction from baseline in mean monthly migraine days compared with 4.2 days observed in the placebo group (p<0.001). All endpoint assessments compared the last four weeks of the 12-week treatment phase to baseline. A reduction of 50 percent or more in number of monthly migraine days was observed in 40 percent and 41 percent (70 mg and 140 mg doses, respectively) of individuals in the erenumab groups at week 12, representing a significantly higher likelihood of response compared to 24 percent of those receiving placebo (both p<0.001). Reductions in monthly acute migraine-specific medication days were 3.5 days and 4.1 days in the 70 mg and 140 mg groups, respectively, representing significant improvements from baseline compared to a 1.6-day reduction in those receiving placebo (both doses p<0.001 versus baseline). All groups showed numeric improvements in cumulative monthly headache hours. Compared to a 55.2-hour reduction versus baseline in the placebo group, reductions were 64.8 hours for 70 mg erenumab and 74.5 hours for 140 mg erenumab. In an analysis of exploratory endpoints, both doses of erenumab were associated with significant improvements in health-related quality of life, headache impact, disability, and level of pain interference, compared to placebo.* "Erenumab is specifically designed to prevent migraine by blocking a receptor that is believed to have a critical role in mediating the incapacitating pain of migraine," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "The results from this global chronic migraine study are exciting because they support the efficacy of erenumab for a patient population that has had few therapeutic options. We look forward to advancing erenumab to help provide a potential new treatment option for patients with this debilitating disease." The safety profile of erenumab was similar to placebo across both treatment arms. No adverse event was reported in greater than five percent of patients treated with erenumab. The most common adverse events (in placebo, 70 mg erenumab, 140 mg erenumab groups, respectively) were injection site pain (1.1 percent, 3.7 percent, 3.7 percent), upper respiratory tract infection (1.4 percent, 2.6 percent, 3.2 percent) and nausea (2.5 percent, 2.1 percent, 3.2 percent). The World Health Organization ranks migraine as one of the most debilitating of all illnesses.1,2 Chronic migraine is the most disabling form of the disease, and is associated with personal and societal burdens of pain, disability and financial cost.3 Results from Phase 3 studies investigating erenumab in episodic migraine are expected later this year. Erenumab is being co-developed by Amgen and Novartis. As part of the collaboration, Amgen retains commercialization rights in the U.S., Canada andJapan, and Novartis holds rights in Europe and rest of world. *Assessment tools for exploratory endpoints including the Headache Impact Test (HIT-6™), the Migraine Disability Assessment (MIDAS), the Migraine-Specific Quality-of-Life Questionnaire (MSQ), and the Patient Reported Outcome Measurement Information System (PROMIS®). Pain Interference Scale Short Form. Exploratory endpoints were not adjusted for multiplicity.
Basically, a placebo reduces 55 headache hours. 70mg = 65 hours, 140 mg by 75 hours. In a month - the drugs benefit really is improving 10 hours or 20 hours. That's 1-2 days of improvement which is significant but since this is an antibody, you know it's going to be super expensive. Like Repatha, will this drug be worth the cost. If I were a payer, I'd mandate they try the placebo first since a fake drug gives you a 2.3 day/55 hour improvement in headaches.
The problem here is not the drug. Migraines are a made up excuse your wife makes because she's tired of having sex with you. Step-edit will be a new pair of shoes. This will lead to a 50%-75% reduction in symptoms. Supplemented by doing the dishes or a load of laundry, 95% symptom clearance can be attained. 100% requires assistance from the pool boy. Science.
As with any migraine drug study there is always a high placebo effect in place. No real reason other than migraines are more of a mental disease. Look at any of the triptans...the placebo effect is very high in every single study! Learn the disease state!
The OP doesn't care about any of that clinical medicine stuff. Just enjoys playing with colors and fonts and colors like a 4th grader in a beginning computer class.
Hilarious! And, spot on. OP is definitely lacking in education. Doesn't know the difference between "their and there".
These results in episodic migraine (from Amgen) further support the use of calcitonin-gene-related-peptide (CGRP) inhibitors for migraine prevention, but also highlight the difficulty in differentiating any one drug from the class given the efficacy and tolerability of all reported thus far. The placebo-adjusted monthly migraine day reduction of 1.1 days reported for AMG 334 in ASPIRE compares favorably with the reduction reported in the Alder (ALDR, OP) ALD403 study of 1 days. Teva’s (TEVA, OP) TEV-48125 produced a numerically greater placebo-adjusted monthly migraine day reduction of 2.5 days, but patients came into the study with a much higher baseline migraine frequency of 11.4 days a month compared to eight days in the AMGN study and roughly nine days in the ALDR study. On a percentage basis, AMG 334 produced a 36% reduction (14% placebo-adjusted), ALD403 a 66% reduction (14% placebo-adjusted), and TEV-48125 a 53% reduction (23% placebo-adjusted). Good data but all three competitors look very similar
