Calcitonin gene–related peptide (CGRP) is a neuropeptide that has both cerebral arteriolar dilating and pain modulation properties.  Decreasing CGRP is thought to increase inhibitory mechanisms which decreases the occurrence of migraine headaches.  There has been a lot of excitement regarding CGRP antibodies that are being developed to prevent migraines. Erenumab is on track to become the first CGRP antibody to be approved in May.

But there is also research for new drugs to treat acute migraine headaches. The drugs are currently forecast to have NDAs submitted in 2019.  Two (rimegepant and ubrogepant) are small molecule CGRP receptor antagonists, also known as gepants. The third is from a new class of drugs to treat migraines that are selective 5-HT1F agonists.  These drugs are also known as ditans.  Ditans are similar to triptans, but are not vasoconstrictors. 

Rimegepant, a gepant, was studied in two Phase III trials with a total of 2,181 patients. 19% of acute migraine patients treated with rimegepant were pain free at 2 hours compared to 14% with placebo. 37% of rimegepant patients were free of their most bothersome symptom at 2 hours compared to 25% with placebo.  Another gepant, ubrogepant, also had trial results recently reported.  In a 1,327 patient, Phase III trial, 20% of patients with an acute migraine treated with ubrogepant were pain free at 2 hours compared to 12% with placebo. 38% of ubrogepant patients were free of their most bothersome symptom at 2 hours compared to 28% with placebo.  The third drug, a ditan called lasmiditan, had results from a trial announced last summer.  In the Phase III SPARTAN trial, 39% of patients with an acute migraine treated with lasmiditan were pain free at 2 hours compared to 21% with placebo. 49% of lasmiditan patients were free of their most bothersome symptom at 2 hours compared to 34% with placebo.

You can review up-to-date information on all migraine drugs with the Prescribe Right Pharmaceutical Pipeline Tracker.

I will be presenting "Pharmaceutical Pipeline 2018 Update" at the St Louis College of Pharmacy On April 7. My presentation is part of the Spring Professional Development Workshops program. I will be discussing investigational drugs that are likely to be reviewed by the FDA in 2018.  I’ll also take a look at cost of new drugs and their impact on pharmacy expenditures.

The program also features 

"Pharmacists of the Future," presented by Sandra Van Trease
“The Intersection of Pharmacy and the Opioid Crisis," presented by Amy Tiemeier
"What's Your Type? Using Myers-Briggs to understand yourself and others," presented by Andrea Guimaraes.
"Courageous Conversations in the Workplace," presented by Susan Stith,

The presentations will be Saturday, April 7, 2018, beginning with breakfast and registration at 7:00 AM. The cost for participation is only $10. The first presentation is at 8:00 AM and my review of the pharmaceutical pipeline will be at 10:30 AM.  The event will take place in the Recreation and Student Center, at the St Louis College of Pharmacy and parking is available in the College’s garage.

You can track these drugs and others in the Prescribe Right Pharmaceutical Pipeline Tracker

According to the American Journal of Managed Care, migraine headache incurs estimated annual costs totaling as much as $17 billion in the United States. Most of the direct costs are for outpatient services: medications, office or clinic visits, emergency department visits, laboratory and diagnostic services, and management of treatment side effects. Indirect costs from lost productivity in the workplace add substantially to the total.

The Mayo Clinic describes migraines as follows: A migraine can cause severe throbbing pain or a pulsing sensation, usually on just one side of the head. It's often accompanied by nausea, vomiting, and extreme sensitivity to light and sound.
Migraine attacks can cause significant pain for hours to days and can be so severe that the pain is disabling. Warning symptoms known as aura may occur before or with the headache. These can include flashes of light, blind spots, or tingling on one side of the face or in an arm or leg.

A search in Prescribe Right’s Pharmaceutical Pipeline Tracker found 8 investigational drugs targeting migraine: six in Phase III; two in Phase II. Eight different pharmaceutical companies are involved in the research. Company approaches to the development have taken five indication pathways. One company has a Phase III trial for migraine prophylaxis and a Phase II trial for episodic migraine prevention. Four companies have Phase III trials and one company a Phase II trial targeting migraine prophylaxis.

If you’d like to review the migraine pipeline, click on this link to a FREE trial of the Pharmaceutical Pipeline Tracker, complete the form and put the words “FREE TRIAL” in the comments section. Your username and password will be sent to you soon​. 

More in-depth knowledge about migraines, can be found on the Mayo Clinic and Statista web sites.

​Nonalcoholic fatty liver disease, an accumulation of fat in the liver, is estimated to occur in almost 1 in 5 adults. With 2 of the most common risk factors being obesity and diabetes, its prevalence is growing. Nonalcoholic steatohepatitis is a more severe form of nonalcoholic fatty liver disease. There are currently no approved drugs to treat nonalcoholic steatohepatitis, but several drugs are being developed to treat this disease. (The full article is available as an Online First article on the Hospital Pharmacy website) 

​Track investigational drugs and find out their current status in the Prescribe Right Pharmaceutical Pipeline Tracker

Acute decompensated heart failure is a sudden worsening of heart failure symptoms, typically resulting in peripheral edema and dyspnea as a result of pulmonary congestion. Acute decompensated heart failure is responsible for over 1 million hospitalizations every year. Current pharmacologic therapy is limited in its options. Despite an improved survival rate, statistic still suggests that about 50% of patients die within 5 years of diagnosis. New pharmacologic agents aim to improve efficacy by targeting previously unexplored physiological pathways. (The full article is available in the March issue of Hospital Pharmacy) 

​You can track these drugs and others in the Prescribe Right Pharmaceutical Pipeline Tracker