CGRP Inhibitors For Migraine Prevention And Treatment | Han Nguyen, PharmD Intern | RxEconsult
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CGRP Inhibitors For The Prevention Of Migraines Category: Pain Management by - March 30, 2018 | Views: 2654 | Likes: 0 | Comment: 0  

CGRP inhibitors for migraines

Introduction

Migraines are headaches that cause pain for hours or days. In addition to severe pain, migraine attacks cause nausea, vomiting, and sensitivity to light and sounds. Migraines are accompanied by sensory warning symptoms or signs such as flashes of light, blind spots, or tingling in the arm or legs. The origin of a migraine is not well understood but it involves the trigeminal system in the brain. Electrical impulse spread to other regions of the brain and changes in nerve cell activity and blood flow. Chemicals in the brain cause blood vessel dilation and inflammation that irritates the trigeminal nerve, resulting in pain. Calcitonin gene-related peptide (CGRP) signals pain in the trigeminal system and it is elevated during a migraine. CGRP causes blood vessels to expand and it also causes inflammation. An infusion of CGRP can trigger a migraine attack. 

 

Calcitonin gene-related peptide (CGRP) inhibitors

 

CGRP inhibitors are monoclonal antibodies that target calcitonin gene-related peptide (CGRP). These medications target CGRP or its receptor. Blocking the action of CGRP inhibits migraine pain transmission and vasodilation. Monoclonal antibodies have a long half-life that’s suitable for chronic prevention. The long duration of action allows less frequent dosing such as once a month or once every three months. These antibodies are also highly specific and selectively target CGRP or its receptor. Galcanezumab, fremanezumab, and eptinezumab target CGRP directly while erenumab (Aimovig) blocks the CGRP receptor.

 

CGRP Inhibitors in Development

 

Erenumab (Aimovig)

 

Manufacturer: Amgen/Novartis

Status: Prescription Drug User Fee Act (PDUFA) target date - May 17, 2018 (Approved)

Indication: episodic migraine, chronic migraine

Dosing: subcutaneous injection

Frequency: every 4 weeks (70 mg, 140 mg)

Common side effects: Runny/stuffy nose, upper respiratory tract infection, injection site pain

Efficacy: Administration of Aimovig resulted in 2.9 to 3.7 fewer migraine days per month compared to placebo.

 

Galcanezumab (LY2951742)

 

Manufacturer: Lilly

Status: Prescription Drug User Fee Act (PDUFA) target date- May 17, 2018

Indication: episodic migraine, chronic migraine, episodic cluster, chronic cluster

Dosing: subcutaneous injection

Frequency: every 4 weeks (120 mg, 240 mg)

Common side effects: injection site reaction and pain, super respiratory tract infection, abdominal pain

Efficacy: Patients suffering from episodic migraines who received galcanezumab for 12 weeks had 4.7 fewer migraine days per month.

 

Fremanezumab (TEV-48125)

 

Manufacturer: Teva

Status: Prescription Drug User Fee Act (PDUFA) target date- June 2018

Indication: episodic migraine, high-frequency episodic migraine, episodic cluster, chronic cluster, chronic post-traumatic headache

Dosing: subcutaneous injection

Frequency: monthly or quarterly (225 mg monthly, 675 mg quarterly)

Common side effects: injection site pain

Efficacy: Patents who received fremanezumab had 3.7 fewer migraine days per month when compared to placebo.

 

Eptinezumab (ALD403)

 

Manufacturer: Alder

Status: filing expected in second half of 2018

Indication: high-frequency episodic migraine, chronic migraine

Dosing: Intravenous infusion every 12 weeks

Frequency: every 12 weeks (100 mg, 300 mg)

Common side effects: upper respiratory tract infection, urinary tract infection, back pain, nausea/vomiting, and joint pain

Efficacy: Patents who received eptinezumab had 4.3 fewer migraine days per month when compared to placebo.

 

Benefits of CGRP Inhibitors

 

Anti-CGRP drugs look promising for the prevention of migraines. These medications are given intravenously every month or every 3 months, which may improve patient adherence. Their efficacy in reducing migraine-free days have been shown in clinical trials and they have fewer side effects when compared to current migraine treatments. There is limited data about their long-term side effects. 

 

References:

 

CGRP: Early Results from Phase III Trials. Migraine.com, 29 Oct. 2017. 

 

Silberstein SD, Dodick DW, Bigal ME, Yeung PP, Goadsby PJ, Blankenbiller T, et al. Fremanezumab for the preventive treatment of chronic migraine. N Engl J Med. 2017;377:2113–22.

 

Tso, Amy R., and Peter J. Goadsby. Current Treatment Options in Neurology, Springer US, 2017. 

 



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