Ibudilast

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Ibudilast is a drug that was developed decades ago in Japan and has been primarily used there since 1989 as an approved treatment for stroke recovery and asthma. It has recently been the focus of trials as a treatment for Multiple Sclerosis and ALS, and there have been some surprisingly promising results. It is NOT approved in the U.S. to treat any disease or condition. Brand names for this oral capsule include Ketas, Pinatos, and Eyevinal.

Overall, more patients taking Ibudilast showed little to no progression as compared to those taking placebo as measured by ALSFRS-R scores.

Trial Name: 

Ibudilast (MN-166) in Subjects With Amyotrophic Lateral Sclerosis (ALS) (IBU-ALS-1201)

ClinicalTrials.gov Identifier:

NCT02238626

Summary: 

This was a 71-person trial that started in September 2014 and completed in December 2017. Positive results are shown in a presentation here.

Trial Name: 

A Biomarker Study to Evaluate MN-166 (Ibudilast) in Subjects With Amyotrophic Lateral Sclerosis (ALS)

ClinicalTrials.gov Identifier:

NCT02714036 

Summary:

This ongoing trial hopes to enroll 35 patients who'll receive 36 weeks of treatment or placebo.

My doctor at MGH suggested this drug as a potential option that would be suitable for my particular form of ALS, which is Upper Motor Neuron dominant. Since Ibudilast is not currently approved in the U.S., it required the support of both my doctor and an organization called The Social Medwork. This group helps individuals import drugs for their personal use that may not be approved in their home country. In the U.S., importation is permitted by the FDA as outlined here. For prescription drugs like Ibudilast, the requirements for importation are: 

• The product is for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means.
• There is no known commercialization or promotion of the product to persons residing in the U.S.
• The product does not represent an unreasonable risk.
• The consumer affirms in writing that the product is for personal use.
• The quantity is generally not more than a three month supply and either: 
  1. Provide the name and address of the doctor licensed in the U.S. responsible for your treatment with the product, or
  2. Provide evidence that the product is for the continuation of a treatment begun in a foreign country.

My doctor provided a letter of support to her contact at The Social Medwork, and I provided the required identification information and payment method as subsequently requested by email from the organization. Ibudilast is not covered by insurance in the U.S. so expect to pay out of pocket. You can find Ibudilast pricing here. At the maximum recommended daily dose of 100mg, expect to pay about $700-$750 for a 3 month supply of 1000 capsules depending on the exchange rate, plus any foreign transaction fees that your credit card may charge. 

The Social Medwork provided a UPS tracking number a few days after my purchase. As my contact at The Social Medwork advised might happen, I had to pay a $25 "Customs Brokerage Fee" directly to UPS after the shipment arrived in the U.S. Oddly, the notice requiring payment (and the link to actually make the payment) only came up when I tracked the package on my phone, not when I used my desktop PC. If your package gets stuck or reverses direction on its way to you, try tracking by phone or calling UPS.