- Khloé Kardashian has experienced migraine since sixth grade and shares her experience with the new migraine therapy NURTEC™ ODT (rimegepant)
- Join Khloé Kardashian and the migraine community in taking back your day from migraine at TakeBackToday.com and share using #TakeBackToday
NEW HAVEN, Conn., July 15, 2020 /PRNewswire/ -- Khloé Kardashian joins efforts with Biohaven Pharmaceuticals to launch the Take Back Today campaign to empower people with migraine to share their stories in an online community, learn about new ways to manage their disease and get back to what matters most – whether that is spending more time with family, friends, a favorite hobby or work. For more than 20 years, Khloé has experienced first-hand the debilitating impact of migraine, an often-misunderstood disease, which inspired her to join this campaign to help other people with migraine.
"Like others, my migraine blindsides me when it strikes and takes away whatever I had planned for my day. When a migraine hits, all I want to do is lie down in a quiet, dark room, and it leaves me feeling isolated and helpless. I dread those migraine days and fear that the migraine pain is going to be bad enough to keep me from being there for my family, friends, work and most importantly, my daughter," said entrepreneur, TV personality, executive producer and mom, Khloé Kardashian. Khloé often faces migraine symptoms such as intense pain, nausea, temporary impaired vision and dizziness. She continued, "For too long, I have also had to deal with the stigma that migraine is just another headache and that I should just 'get it over it.' People don't understand how disabling migraine can be, especially when I have to cancel plans at the last minute."
Khloé has been working with her doctor to better manage her migraine and she recently started using NURTEC™ ODT (rimegepant), an orally dissolving tablet that is an acute treatment. Khloé stated, "For me, NURTEC ODT was different than other treatments I tried. NURTEC ODT worked fast and allowed me to get back to normal so that I could take back my day. I'm sharing my story so others with migraine do not feel alone and can be empowered to Take Back Today from migraine."
In clinical trials, the most common adverse reaction was nausea (2% in patients who received NURTEC ODT compared to 0.4% in patients who received placebo). Hypersensitivity, including dyspnea and rash, occurred in less than 1% of patients treated with NURTEC ODT.
Khloé Kardashian adds, "I want to encourage people with migraine not to give up hope and to continue to work with their doctor to find something that works for them. Together, we can build a strong community for people with migraine to express themselves without judgement and learn from others how to get back to what they love."
Nearly 40 million people have migraine, most of whom are women. A recent survey, Perspectives of People with Migraine by the National Headache Foundation and Biohaven, confirms that 93 percent of people who don't suffer from migraine fail to understand the severity of the disease. With Take Back Today, Khloé hopes that other people living with this debilitating disease join her on TakeBackToday.com or share their story using #TakeBackToday.
Vlad Coric, M.D., CEO of Biohaven commented, "It's impressive how much Khloé Kardashian has accomplished in her career and for her family despite her longstanding struggle with migraine since childhood. Khloé's story resonates deeply with so many other people with migraine and adds to what we have heard from them about the disruptions they experience in their daily lives and how NURTEC ODT has made a difference. I was particularly moved by Khloé's stories about how migraines have impacted her life since sixth grade and how well she has responded to NURTEC ODT. The Take Back Today campaign speaks to Biohaven's commitment to patients and communicates the importance of NURTEC ODT as a new acute treatment of migraine for the millions of people suffering from the disease that are not satisfied with their current therapy. We are grateful to Khloé for her advocacy and passion to help others by sharing her own experience with migraine and her treatment response to NURTEC ODT."
NURTEC ODT is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist in an orally disintegrating tablet (ODT) approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine in adults. NURTEC ODT is not indicated for the preventive treatment of migraine. A single dose of NURTEC ODT can provide fast pain relief and return patients to normal function within one hour, and deliver sustained efficacy that lasts up to 48 hours for many patients. The fast-dissolve tablet disperses almost instantly in a person's mouth without the need for water, offering people with migraine a convenient, discreet way to take their medication when and where they need it.
The World Health Organization classifies migraine as one of the 10 most disabling medical illnesses. Migraine is characterized by debilitating attacks lasting four to 72 hours with multiple symptoms, including pulsating headaches of moderate to severe pain intensity that can be associated with nausea or vomiting, and/or sensitivity to sound (phonophobia) and sensitivity to light (photophobia). There is a significant unmet need for new acute treatments as more than 90 percent of migraine sufferers are unable to work or function normally during an attack.
About NURTEC ODT
NURTEC™ ODT (rimegepant) is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a quick-dissolve ODT formulation that is approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine in adults. The activity of the neuropeptide CGRP is thought to play a causal role in migraine pathophysiology. NURTEC ODT is a CGRP receptor antagonist that works by reversibly blocking CGRP receptors, thereby inhibiting the biologic activity of the CGRP neuropeptide. The recommended dose of NURTEC ODT is 75 mg, taken as needed, up to once daily. For more information about NURTEC ODT, visit www.nurtec.com.
The most common adverse reaction was nausea (2% in patients who received NURTEC ODT compared to 0.4% in patients who received placebo). Avoid concomitant administration of NURTEC ODT with strong inhibitors of CYP3A4, strong or moderate inducers of CYP3A or inhibitors of P-gp or BCRP. Avoid another dose of NURTEC ODT within 48 hours when it is administered with moderate inhibitors of CYP3A4.
NURTEC™ ODT (rimegepant) is indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use
NURTEC ODT is not indicated for the preventive treatment of migraine.
Important Safety Information
Contraindications: Hypersensitivity to NURTEC ODT or any of its components.
Warnings and Precautions: If a serious hypersensitivity reaction occurs, discontinue NURTEC ODT and initiate appropriate therapy. Serious hypersensitivity reactions have included dyspnea and rash, and can occur days after administration.
Adverse Reactions: The most common adverse reaction was nausea (2% in patients who received NURTEC ODT compared to 0.4% in patients who received placebo). Hypersensitivity, including dyspnea and rash, occurred in less than 1% of patients treated with NURTEC ODT.
Drug Interactions: Avoid concomitant administration of NURTEC ODT with strong inhibitors of CYP3A4, strong or moderate inducers of CYP3A or inhibitors of P-gp or BCRP. Avoid another dose of NURTEC ODT within 48 hours when it is administered with moderate inhibitors of CYP3A4.
Use in Specific Populations:
Pregnant/breast feeding: It is not known if NURTEC ODT can harm an unborn baby or if it passes into breast milk.
Hepatic impairment: Avoid use of NURTEC ODT in persons with severe hepatic impairment.
Renal impairment: Avoid use in patients with end-stage renal disease.
You are encouraged to report side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088 or report side effects to Biohaven at 1-833-4Nurtec.
Biohaven Pharmaceuticals is a wholly owned subsidiary of Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) and a biopharmaceutical company focused on the development and commercialization of innovative best-in-class therapies to improve the lives of patients with debilitating neurological and neuropsychiatric diseases. Biohaven's neuroinnovation portfolio includes FDA-approved NURTEC™ ODT (rimegepant) for the acute treatment of migraine and a broad pipeline of late-stage product candidates across three distinct mechanistic platforms: CGRP receptor antagonism for the acute and preventive treatment of migraine; glutamate modulation for obsessive-compulsive disorder, Alzheimer's disease, and spinocerebellar ataxia; and myeloperoxidase (MPO) inhibition for multiple system atrophy and amyotrophic lateral sclerosis. For more information, visit www.biohavenpharma.com.
This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including "believe", "continue", "may", "will" and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of Biohaven's management about NURTEC ODT as an acute treatment for patients with migraine and potential preventive treatment for migraine. Factors that could affect these forward-looking statements include those related to: Biohaven's ability to effectively commercialize NURTEC ODT, delays or problems in the supply or manufacture of NURTEC ODT, complying with applicable U.S. regulatory requirements, the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials, the timing of planned interactions and filings with the FDA, the timing and outcome of expected regulatory filings, the potential commercialization of Biohaven's product candidates, the potential for Biohaven's product candidates to be first in class or best in class therapies and the effectiveness and safety of Biohaven's product candidates. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements. Additional important factors to be considered in connection with forward-looking statements are described in the "Risk Factors" section of Biohaven's Annual Report on Form 10-K for the year ended December 31, 2019, filed with the Securities and Exchange Commission on February 26, 2020 and Biohaven's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, filed with the Securities and Exchange Commission on May 7, 2020. The forward-looking statements are made as of this date and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Vlad Coric, M.D.
Chief Executive Officer
Sam Brown Inc.
NURTEC is a trademark of Biohaven Pharmaceutical Holding Company Ltd.
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.