FDA Approves Pitolisant for Daytime Sleepiness in Patients with Narcolepsy

https://www.pharmacytimes.com/news/...aytime-sleepiness-in-patients-with-narcolepsy

Wonder if this could help with fatigue in mecfs?

 

Dr Cheney did work on diastolic heart failure in ME. He believed we were protected from needing heart transplants (as happens with systolic heart failure) because we are forced to rest when our heart needs it.

Also our brains are fragile so revving them up could damage our brains and our hearts. He advised against taking any anti fatigue medicine.

I agree with this, because solving the fatigue will not help the underlying problems. The most dagerous point with ME is when we feel better as we do to much and get bad PEM.

I thought I was cured at one point and did too much. Have been unable to walk more than a few steps for the past 30 years.

 

Just skim read the article, struggling with the technical terms today, but sleepiness and fatigue are not necessarily the same.

Sometimes some of us are very sleepy and can sleep excessively, but that is not true for everyone or true all the time for those that it involves.

Fatigue may mean you feel a need for sleep but does not necessarily mean you will sleep more, it can also be associated with sleeping less.

 

Does anyone from Solve/MECFS and OMF read this?

Get in contact with Harmony Biosciences business development and ask for a donation of product to start a trial, crossover amphetamine crossover placebo.

 

Because it also aids in “improved cognition, as evidenced by increased processing speed and improved mental clarity.” at least in PWS, i.e., less brain fog.

 

https://twitter.com/user/status/1712825902176846316



Harmony Biosciences just announced a failure of their phase 3 idiopathic hypersomnia (unexplained sleepiness) trial. This was a junk, low-bar trial that no one expected to fail. Blows up their entire story and undermines their previous data upon which FDA approval was based. Implications;

1. Investors and sell side have been hanging their hats on label expansion given Walkix is at saturation for its only current indication (excessive daytime sleepiness and cataplexy in adults who have narcolepsy). Label expansion story is now out the window.

2. Their previous trials were conducted in low quality foreign jurisdictions like Russia. This trial appears to have been their only one conducted in the US, which makes it harder to use the same tricks (as detailed in our report). This undermines their previous data upon which they received FDA approval and confirms those studies were not to be trusted or believed.

3. We had assumed this trial was a failure given changes to the study record on ClinicalTrails.gov (see screenshot below), but figured they would fake or manipulate the data to kick it over the stat sig line. A cesspool of changes to the study protocol which suggested a desperate attempt to move the goal post.

In particular, the last record change showed a sudden unplanned trial size expansion from 200 to 214 patients. This usually suggests a failed trial and an attempt to scrounge statistical significance by jamming more patients into the sample size. URL to track changes;

classic.clinicaltrials.gov/ct2/history/NC…

4. This trial was an even lower bar than their junk foreign trials. Their trials exhibit a rapidly shrinking study duration, b/c the drug has a supernormal discontinuation rate due to lack of efficacy and side effects. The foreign trials went from 8 week to 7 week duration - already absurdly short and arbitrary for a drug that purports to address a lifelong condition . Shockingly, this IH ttrial cut the duration in half and measured change in sleepiness over only a 4 week period - yet it still failed.

5. Even if this trial had “worked” it wouldn’t have expanded patient counts. We believe the drug is already prescribed off label for IH which is the only way they’re able to show these patients counts given the tiny patient population for narcolepsy. Even their highest volume prescribers - in their speakers program, no less - told us an IH approval would not move the needle in their scrip numbers.