Drug manufacturer Novartis announced that its experimental drug can cut the number of migraine days a person has by half. This is potentially good news, especially since the drug seems to have a good safety profile so far.
But in the meantime, drug-free migraine reduction with TMJ treatment can be very effective for the right candidates.
Significant Migraine Reduction
In a Phase II clinical trial involving 667 people, Novartis’ drug AMG 334 (also called erenumab), reduced the number of migraine days people had by half for about 40% of migraine sufferers. This reduction was seen in 40% of those taking a 70 mg dose, and 41% of those receiving a 140 mg dose. Overall, patients saw an average of 6.6 fewer migraine days from their baseline.
If you’ll remember, erunumab initially had disappointing results, but it’s turning out more effective than it initially seemed.
Erenumab is delivered once monthly as a subcutaneous injection. The study results reported here were from a 12-week placebo-controlled trial. Erenumab is one of a family of CGRP inhibitors. CGRP (calcitonin-gene-related peptide) is a compound released by the trigeminal nerve and other nerves as part of the causal chain of migraines. It has also been implicated as a potential link between TMJ and other chronic pain conditions, such as fibromyalgia and irritable bowel syndrome (IBS).
The drug was actually invented by Amgen, but is being developed by Novartis as part of an agreement between the two companies. Amgen will retain the rights to sell the drug in the United States, Canada, and Japan, while Novartis will be able to sell the drug in Europe and the rest of the world, if it received regulatory approval.
Powerful Placebo
Although erenumab outperformed placebo by a statistically significant margin, the trial still shows a strong placebo effect. People taking placebo injections also saw a significant decrease in their migraine days.
Overall, placebo recipients saw an average of 4.2 fewer migraine days compared to baseline. That’s 63% of the effect of the actual drug. And the results were similar for the number of people who saw a 50% reduction in migraine days. Nearly a quarter of those taking placebo (24%) saw their migraine days cut in half–that’s a big boost just for using a placebo.
In the Pipeline
Erenumab is one of four CGRP inhibitors currently in development. Although these drugs seem promising, they’re still in the midst of their clinical trial process. The clinical trial process is broken into three phases.
Phase I trials are small, involving 20 to 100 healthy individuals with the condition. The purpose of this phase is to determine whether drugs are safe, and to attempt to discover what is the effective dosage.
Phase II trials–which is the stage erenumab has reached–involve several hundred people. This trial is intended to determine whether the drug is actually effective at the potential dosages and determine whether there are serious side effects. So far, erenumab seems to have a safety profile similar to placebo.
Phase III trials can involve up to several thousand people and take at least one year to complete. These trials ensure that the drug is actually effective when used properly, and to watch out for potential adverse reactions that may not be seen after just a few doses.
Phase IV trials can take several years and involve tens of thousands of people. Phase IV trials are actually postmarketing surveillance, and take place after a drug has been approved.
Based on its place in the clinical trial system, erenumab will likely not be ready for approval for at least another year, possibly more. Although this drug is promising, it doesn’t represent a good alternative for people who need headache help today.
But drug-free TMJ treatment may be able to help with your migraines in Columbia, SC. Please call (803) 781-9090 today for an appointment with a TMJ dentist at Smile Columbia Dentistry.
