In Japan Botox is not officially approved to oromandibular dystonia (jaw closing dystonia, jaw opening dystonia, jaw protrusion dystonia, jaw deviation dystonia, and lingual dystonia). I would like to know in which countries Botox has been approved to oromandibular dystonia.
In the Netherlands, botox is approved and used to treat this condition.
Dear Dr. Victor Geraedts,
Thank you very much for the information.
Best regards,
Kazuya Yoshida
Hi Kazuya,
We can use it here. There is an insurance payment.
I hope, I have helped you.
All the best.
Mehmet Güney
Dear Dr. Mehmet Güney,
Thank you very much for your information.
I am collecting information so that Botox is officially approved for oromandibular dystonia in Japan.
Best regards,
Kazuya Yoshida
In France, botox is approved too (by oral and maxillo-facial surgeons).
Dear Dr. Thomas Colard,
Thank you very much for your response.
Since 1992, I have been administering Botox for oromandibular dystonia.
However, in Japan Botox has NOT been OFFICIALLY approved. I have been using it with diagnosis of hemifacial spasm. I have attempted to be able to use Botox officially. If Botox is approved in one of 6 countries (USA, UK, Canada, France, Germany, or Australia), it could be approved officially in Japan. I asked about it the person in charge. He sent me a PDF file. The PDF file contained approval status of all countries. Unfortunately, Botox has NOT approved OFFICIALLY in above 6 countries.
Best regards,
Kazuya Yoshida
Dear Yoshida san, in the EU and US neither Botox, nor Dysport, nor Xeomin, nor Myobloc is approved for OMD. You may review: Comella: Systematic review of botulinum toxin treatment for oromandibular dystonia. 2018.Extract from the SmPC: BOTOX is indicated for: Neurologic disorders: • treatment of focal spasticity, including: dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients, two years of age or older wrist and hand disability due to upper limb spasticity associated with stroke in adults ankle disability due to lower limb spasticity associated with stroke in adults • symptomatic relief of blepharospasm, hemifacial spasm and idiopathic cervical dystonia (spasmodic torticollis) • prophylaxis of headaches in adults with chronic migraine (headaches on at least 15 days per month of which at least 8 days are with migraine).
Best regards,
Janos
Dear Dr. Janos Csisko,
Thank you very much for information on botulinum toxin. Botulinum toxin has been used clinically for oromandibular dystonia in many countries. Why is the toxin not approved? Randomized control trials with larger number of patients with oromandibular dystonia must be required to elucidate the therapeutic efficacy of the botulinum toxin.
Best regards,
Kazuya Yoshida
Dear Joshida san, the approval of this drug for omd is depending on the expected net present value of the indication, which primarily leads the expectations and financial interest of the manufacturing company. If the patient population is small or heterogenious and the other opportunities look better (higher net present value, lower developmental costs) the company will not consider to develop the drug for this indication, but for the more lucrative indication (e.g. spasticity or migraine).
I know this is not satisfying patients, however for the sake of the existence of the company such strategies are essential. Best regards, Janos
Dear Dr. Janos Csisko,
Thank you very much for your comment. I understand what you mean. However, the prevalence of oromandibular dystonia must be much higher than previously expected. Nearly 90% of my patients with oromandibular dystonia had not been either diagnosed or suspected to have oromandibular dystonia. The patients visited 4.1 hospitals for 3.8 years to obtain the diagnosis of oromandibular dystonia. I hope the manufacturing company can consider to be approved the botulinum toxin for oromandibular dystonia.
Yours sincerely,
Kazuya Yoshida
Dear Dr. Kazuya Yoshida san, thank you very much for your comment and insights on your patient population. Best regards, Janos Csikos
I was informed that Botox is approved in the following 100 countries. However, I do not know what indications are available in each country. If you know, I would appreciate it if you could tell me.
Argentina, Aruba, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Barbados, Belgium, Bolivia, Brazil, Brunei, Bulgaria, Canada, Cayman islands, Chile, China, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech republic, Denmark, Dominican republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kenya, Korea, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macao, Malaysia, Malta, Mauritius, Mexico, Morocco, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestinian territory, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovak republic, Slovenia, South Africa, Spain, Sri Lanka, St. Maarten, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab emirates, United Kingdom, United States, Uruguay, Venezuela, Vietnam
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