Discontinuance of Campaign towards Approval of Buccolam® in Japan

Thank you so much to everyone who helped us collect signatures for the approval of Buccolam® in Japan.

We, regrettably, have to inform you of the suspension of this campaign. Thanks to the hard work of Dravet Syndrome Japan, a family group consisting of parents and caregivers of patients with Dravet Syndrome, a number of the strict conditions concerning the clinical trials of Buccolam® have been alleviated.

Our first goal for this campaign was to alleviate those conditions, and thus, our plan to bring to the Minister of the Health, Labor and Welfare the signatures you have provided us. However, now that this goal has been reached, the continuation of this campaign is no longer necessary.

More than 30,000 signatures have been collected throughout this campaign, however, and we cannot thank you enough for your kind support. We did not get a chance to bring the signatures to the Ministry of Health, Labor and Welfare, yet it is certain that the alleviation of the conditions to conduct clinic trials was a big step forward towards the approval of Buccolam® in Japan.

We will work hard while continuing our cooperation in any clinical trials until we reach our final goal which is to have Buccolam® in the hands of parents and caregivers of patients of Dravet Syndrome to save more lives which would otherwise be impossible.

 

 

 

 

Help Dravet kids through this petition!

Could you help my kid with Dravet syndrome?

Dravet syndrome is a rare, catastrophic, lifelong form of epilepsy and it is said that it affects 1 in every 15,700 individuals. Since patients with Dravet syndrome often have prolonged seizures, they face a 15-20% mortality rate.

We are now collecting signatures for Buccolam®’s approval in Japan. Buccolam® is a type of medicine used for the treatment of prolonged convulsive epileptic seizures in children, and it could be a medicine that saves patients with Dravet syndrome from losing their lives.

We collected the signatures for its approval three years ago, and clinical trials have finally begun. Unfortunately, the conditions of these trials are too strict and there has not been enough data collected to pass this trial stage. There are only few facilities carrying out these trials nationwide, and they are carried out only during the daytime on weekdays, both of which makes it extremely hard to conduct trials due to the small number of patients available. Also, the age limit makes it even harder to collect data.

Thus, we have decided to collect signatures again to alleviate trial conditions and to allow the referral of data collected in counties outside of Japan using Buccolam®.

Delaying the approval of Buccolam® means losing more lives. We cannot wait any longer. If you could support us in this petition, please click the red button on the bottom for your signature.

Please refer to the following for the announcement for the promoted petition you will see after you agree:

https://help.change.org/s/article/Promoted-Petitions-FAQs?language=en_US

For more info about Dravet syndrome, please refer to the following:

https://www.dravetfoundation.org/what-is-dravet-syndrome/

For more info about Buccolam®, please refer to the following:

https://patient.info/medicine/buccal-midazolam-for-seizures-in-children-buccolam

http://chng.it/gMJHxg2p