Dextromethorphan
What is it?
Delsym 12 hour contains detromethorphan polistirex, a slow release formulation of dextromethorphan. Multiple clinical trials have shown that the proprietary drug Nuedexta, which is actually a combination of the two generic drugs dextromethorphan hydrobromide and quinidine sulfate, is effective against Pseudobulbar Affect (PBA). Dextromethorphan hydrobromide is the active ingredient in Nuedexta, while the quinidine sulfate is used to boost its levels in the bloodstream by minimizing its breakdown by digestion.
PBA is a condition not uncommon among ALS and Multiple Sclerosis patients that causes extreme physical reactions of happiness or sadness even when the actual emotions being experienced would not otherwise justify those reactions. The symptoms are involuntary laughing or crying that occurs frequently and can be either provoked by an event or come on for no apparent reason. This can be frustrating and embarrassing for the patient as well as caregivers.
During the Nuedexta trials for PBA (as well as during prescribed use) many ALS patients in those studies reported improved speech and swallowing, which had not been an anticipated result from taking this drug. The following study was commissioned to look specifically at that finding.
Nuedexta ALS Trial 1
Trial Name: Clinical Trial Nuedexta in Subjects With ALS
ClinicalTrials.gov Identifier:
Summary:
This double-blind and placebo-controlled trial started in April 2013 and enrolled 60 patients. Half received Nuedexta, and half received a placebo for a month, and then after a break the groups were reversed.
Effectiveness as Measured by Center for Neurological Study Bulbar Function Scale (CNS-BFS) Total Score:
Patients on Nuedexta scored on average a 53.5 on the scale, as compared to 59.3 for those on the placebo. The scale scores range from 21-105, and the lower the score, the better a patient can speak, swallow, and handle salivation. Since about a quarter of the patients did not respond at all to the drug (as reported here), it could be inferred that those who did respond saw a more dramatic effect than the above average scores would imply.
My personal Dextromethorphan experience
I brought up the potential use of Nuedexta (or alternatively taking the two individual generic components separately) to my doctor in March of 2017. I did not have any speech or swallowing issues at that time but it is my personal belief that a treatment that can improve symptoms has a decent chance at delaying the onset of those symptoms, especially when they are likely inevitable. My doctor, and subsequently my wife, was concerned about the use of quinidine sulfate as it is used to prevent irregular heartbeats and is not taken without risk.
As a safer (and much less expensive) alternative, my doctor recommended Delsym 12 hour. The dextromethorphan polistirex it contains simply means that it is dextromethorphan surrounded by an edible plastic coating (polistirex) that slows digestion and makes more of the drug available over a longer period (hence the 12 hour effectiveness). I ramped up to my current 10ml 2X daily dose (20ml per day total) in May 2017 and have been taking it continuously ever since. I did need to have it approved as acceptable to take during my BrainStorm Phase 3 trial enrollment.
As for results, I can say that any speech, swallowing, and saliva issues didn’t start to appear until about 18-19 months after diagnosis. They are still minor and very manageable, although what my state now would be had I never taken Delsym will be forever unknown. We’ve heard anecdotal evidence from other PALS (People with ALS) that they believe it has improved their previously existing issues since starting. I want to make it clear that no clinical trial has ever used Delsym (as opposed to Nuedexta) and its use should be discussed with your doctor first.