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Wednesday, 28.10.2020

Samuel Gershon: The emergence of “new” drugs in recent years

 

        In the last few years there have been attempts to market “new” psychiatric drugs, as well as older ones, for an increasing range of therapeutic indications.

        Some of the “new” ones seem to try and get approval from the FDA by suggesting that they have special qualities that would justify some special exception that  might make the drug qualified for some exceptional approval aspects.  

Two examples:

1. IV Ketamine. Usage has been in place for many years and over the past several years it has become more popular with the claim  that it was “simple,” rapidly effective and inexpensive. All this activity without a real commercial sponsor.     

2. Nasal inhalation of a ketamine spray, the “Big   Breakthrough.” This version entered the market with big commercial backing. The claims ranged from

a. rapid onset of action,

b. good efficacy in the elderly depressed patient, and

c. only a few treatments are required.

        Both forms of  ketamine treatment have received FDA approval.  

        Another “new one” is Zuranalone. It is marketed in Australia by the manufacturer Lundbeck; in the US it is marketed by a Boston company, Sage.  It has a different trade name in each country.  This product was originally marketed for post-partum  depression (PPD), presented as a significant and unique feature. Now, as is often the case, the indications are spreading to all depressions.

Again, the “special features” claim is made  based on:

a. rapid action, 

b. a unique compound,

c. a unique mode of action, and

d. it leads to other new compounds 

        This compound has apparently obtained FDA approval and is being advertised and marketed in Australia. In the US, Sage had submitted and expected FDA approval, but this has apparently been delayed or removed. In the published ads about whether or not it should be used in bipolar disorders, the highlight was  its unique quality of special effect in PPD.  A mentioned side effect was that it may precipitate manic features, but offered no mention of its safety in patients with bipolar features.

        Finally, there is Vraylar. This is a cute offering  for {mania}mixed states}depression}; that is, for each one or any or all the different indications.  

        I will stop now but wonder if there is some feeling in the field that there has been no new pharmacological developments for years and, thus, a big return to oldies (hallucinogens) for different indications and all sorts of add-on psychotherapies.

 

October 8, 2020