What is the difference between FDA cleared vs. FDA approved?

Orange County Migraine & Headache CenterFDA approval is a more rigorous process and is required for any prescription medication brought to the market for use in the US. For example: for a new acute medication for the treatment of migraine (examples Ubrelvy, Nurtec, and Reyvow)-efficacy that is statistically significant over placebo has to be demonstrated. Safety also has to be proven in long-term safety trials. In comparison, devices such as Cefaly and Nerivio only need FDA clearance to be available for use in the US.  The standards for getting FDA clearance are not as rigorous. These devices have to demonstrate a good safety profile but the requirements for efficacy over placebo are not as strict.

 

To make an appointment, please call 949-861-8717.

I heard a new device was just approved for migraine in the US. Can you tell me more about it?

Orange County Migraine & Headache CenterRelivion was FDA cleared for use in the US for migraine on 3/02/2021. It is a non-invasive, multi-channel neuromodulator system which stimulates 6 branches of the occipital and trigeminal nerves. In one study of 131 patients, 46% using the active device experienced pain freedom at 2 hours compared to only 11.8% in the sham (placebo) group. It is not yet commercially available for our office to prescribe. Hopefully it will be available soon. To learn more go to www.neurolief.com

This is now the fifth non-invasive device FDA cleared for use in the US. The other four are the Cefaly device, sTMS, GammaCore and Nerivio.

To make an appointment, please call 949-861-8717.

Winter Newsletter 2021

Dear Patient,

Happy New Year 2021! Many of us were glad to say good-bye to 2020 but admittedly, 2021 has had its challenges with ongoing COVID-19 cases, vaccination glitches, political unrest, and financial stress. Our practice is committed to being there for you during this time.

All of us have now been vaccinated and continue to take special precautions in sanitizing our office and limiting the number of you that come in at any one time. Many of you have appreciated the convenience of virtual phone visits for follow-up and we will continue to offer that option for existing patients.

We are very excited to announce the addition of two new staffmembers to Orange County Migraine & Headache Center. Jamie Kolak is our new front office receptionist and works from 8:15 am-1 pm Monday-Thursdays. She brings 14 years of medical front office experience with her and has great communication skills. Aurora continues to work full-time as our certified medical assistant (CMA) and will now be able to devote more time to back office responsibilities, Botox approvals, and prescription refills. Bailey, our other receptionist, is completing her dental hygiene training and has had to reduce her hours; however, she still devotes time to non-Botox prior authorizations and billing. We are proud of all three of them. They make a great team.

Our other new addition is Allison Kennedy, a Physician Assistant (PA), who is available to see headache patients on Wednesday afternoons. She has over 5 years of experience seeing headache patients and is skilled with Botox injections for migraine patients, nerve blocks, and evaluation of headache. We anticipate her hours to increase over time.

Dr. Hutchinson and Dr. Molly Rossknecht continue to provide care for headache and mood disorders. We continue to strive to provide compassionate and state-of-the-art treatment for headache and mood disorders. A patient survey will be offered in the near future providing valuable feedback on how we are doing and what we can do better. Your feedback is greatly appreciated.

And behind the scenes is our hard-working office and business manager, Norma Colgan. She continues to be our “silent hero.” Our practice could not run without her.

We look forward to continuing to service you, our patient, in 2021, and welcome your feedback. May 2021 be a year of renewal and healing for us as individuals, for our country, and for our world.

Drs. Susan Hutchinson, Molly Rossknecht & staff

Should I delay getting Botox or injecting with my CGRP mAB (Aimovig, Ajovy, or Emgalit) before or after receiving the COVID-19 vaccine?

Orange County Migraine & Headache CenterThere is no data available that supports delaying any specific migraine therapy during the time of receiving the COVID-19 vaccine. We encourage all of you to continue with your current migraine treatments AND get the vaccine as soon as it is available to you. To learn more about COVID-19 resources for those with migraine go to https://americanheadachesociety.org/covid-19-resources/

To make an appointment, please call 949-861-8717.

Holiday Message December 2020

Dear Patient,

We want to say goodbye to 2020 filled with COVID-19 invading our lives, economic and political unrest, and just the uncertainty of daily life. We have all had to adapt in ways that have adversely affected our life and caused undue anxiety, stress, and unhappiness. For many of you, your migraine pattern may have worsened.

Our practice has remained open to take care of your needs. We are very grateful that most of you have been receptive to us practicing virtual medicine by reviewing your medical issues over the phone. We anticipate many of you may want to continue handling follow-up visits by phone even after vaccinated for COVID-19. Phone visits can be convenient and still provide a thorough review of how you are doing with your headache and/or mood disorder issues.

For those choosing to come in person we can accommodate you. This has been important for those of you needing a Botox procedure, a nerve block procedure, a Toradol injection, or simply a preference for an in-person visit. We will continue to take your temperature and screen for COVID-19 prior to entering our office. Disinfecting the exam rooms in between patients and disinfecting all office surface areas will continue to be a top priority to help you feel safe in our office.

On an optimistic note, new migraine-targeted treatments have become available in 2020 including Ubrelvy, Nurtec, and Reyvow for the acute treatment of migraine attacks. Vyepti, an IV CGRP targeted treatment for the prevention of migraine, has also become available and is helping many of our patients who like the convenience of an IV medication administered over 30 minutes every 3 months at a local Infusion Center in Irvine that we are affiliated with.

May you & your loved ones have a safe & joyous Holiday Season. We look forward to 2021 and helping you towards improved health.

Warm regards,

Dr. Susan Hutchinson & Dr. Molly Rossknecht

Orange County Migraine & Headache Center