U.S. - FDA approves benzodiazepine Byfavo (remimazolam) for procedural sedation

[S.J.B.]

FDA approves Byfavo for procedural sedation
The Pharma Letter
July 3rd, 2020

The US Food and Drug Administration has approved Byfavo (remimazolam) for injection for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less, marking the second approval for UK-based Acacia Pharma (Euronext: ACPH) this year, extending its portfolio of anesthesia products, and sending the firm’s shares up 10.8% to 3.28 euros by mid-morning today.

Acacia Pharma in-licensed the commercial rights to Byfavo for the US from Cosmo Pharmaceuticals in January 2020. Remimazolam was developed by Germany’s Paion, which will receive a milestone payment of 15 million euros ($16.8 million) from Cosmo and is entitled to tiered royalties on net sales in the USA ranging from 20% to 25%.

The approval of Byfavo will help to further strengthen Acacia Pharma’s financial resources, as previously announced, the company will now have access to an additional 25 million euros debt facility from Cosmo. Acacia Pharma will make a 30 million-euro upfront payment for the license of Byfavo to Cosmo, triggered by the approval, consisting of 15 million euros in cash and 15 million euros in ordinary shares of Acacia Pharma stock. The 10 million euros of net cash that Acacia Pharma will receive will be available to help fund the US launch of [Byfavo.]

Read the full story here.

Remimazolam:

 

[S.J.B.]

It was placed into Schedule IV by the DEA.

 

[thegreenhand]

curious what sort of novel activity it has

but with a fresh patent, that may take a while to be public knowledge

 

[Cream Gravy?]

No doubt it will be used for the sick purposes of lethal injections like midazolam has been for over a decade.

It's straight up unfair that prisoners on death row get barbs and benzos before death but I have to go three different doctors to get a measly alpraz script for otherwise untreatable IBS...

 

[Skorpio]

curious what sort of novel activity it has

but with a fresh patent, that may take a while to be public knowledge

Ultra short duration due to metabolism by plasma esterases rather than hepatic cytochrome p450 enzymes. Also, it can be administered continuously for a long amount of time without altering the pharmacokinetics, as one would see with a cyp450 substrate.

Its the same medchem trick that was used to develop remifentanil, which is quite the tool for anesthesiologists.