A non-Corona Virus Posting: Teaching a really ancient drug a new trick

But First, the Cocaine Saga Continues

In Supplement 10 of Orange Book Volume 39 Genus Lifesciences listed another patent (10,420,760) for its cocaine hydrochloride product, GOPRELTO. It is the fourth method patent listed for GOPRELTO that is directed to a method of inducing local anesthesia. In this case, the inventors added the patient’s glomerular filtration rate as a new limitation in the claims. 

Teaching a Really Ancient Drug a New Trick

We all know of a really ancient drug (think back to biblical times!) that is still widely used today. That is ethyl alcohol (a.k.a. “ethanol” or simply “alcohol”). Of course, it is used mainly as a recreational drug. But then again, you may have known or heard of people who imbibed a distilled spirit on a regular basis strictly for “medicinal purposes.” I can still recall seeing my dad taking a single shot of some sort of whiskey every evening after dinner. Although I do not think I ever knew his medicinal purpose.

I recently discovered that ethanol is an Orphan Drug! After my computer application creates the latest update of my Orange Book Companion® I generally select a few pages to make sure that the data is in good order. It was there, on the page containing drugs whose trade name begins with “A,” that I recently discovered ABLYSINOL which has Orphan Drug exclusivity. ABLYSINOL is 99% alcohol and its route of administration is “intra-arterial.” In other words, it is nearly pure ethanol that is administered directly into an artery! Amazing! 

So what is the orphan indication for which ABLYSINOL was approved? Here it is in words that only a cardiologist could love:

ODE-192: Indicated to induce controlled cardiac septal infraction [sic, “infarction”] to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy.

Since I am not a cardiologist, or even a doctor, out onto the web I went to research this indication. I found that “septal” concerns the heart’s septum which is the wall that divides the left and right sides of the heart. “Hypertrophic obstructive cardiomyopathy” is a largely inherited heart cell defect that causes the cells to enlarge and potentially cause problems. The “controlled cardiac septal infarction” is carried out by administering the nearly pure ethanol directly into the heart via the intra-arterial route to kill the enlarged cells. Killing those abnormal cells can help the heart work better, and so hopefully improves the exercise capacity of the patient.

The above is my simplistic layman’s interpretation of the orphan indication. If you would like to learn more about hypertrophic obstructive cardiomyopathy, you can read about it on the American Heart Association’s web page on the subject.

If you would like to learn how the intra-arterial administration of the ethanol to the patient’s heart is carried out, there is a nice abstract in the NIH’s Pubmed database at a time when the procedure was still experimental.

So, no matter how old a drug may be, it is never too late to teach it a new trick!


Popular posts from this blog

Make sure that your patent exists before submitting a 3542 form for the patent to the FDA

Orange Book V43, Supp. 1 news

The Chicken Sandwich Conundrum: Parts is Parts . . . or Not