Brixadi

[Sushirolls]

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https://mb.cision.com/Main/13456/2715933/975197.pdf
Here is the excerpt that has my ire:
With the tentative approval, Brixadi has met all regulatory standards of clinical and non-clinical safety, efficacy and quality for US approval. However, final approval of a monthly depot is according to the FDA subject to the expiration of an exclusivity period granted to Sublocade™. The restriction period may not last longer than November 2020, but both the scope and duration could be reduced if successfully challenged.

This has me frustrated. Sublocade is the inferior product, when compared on paper. I hope this is challenged and they release it stat. Brixadi can quell many of the REMS issues in one fell swoop and have so much greater ease in prescribing than sublocade.

 

[QofQuimica]

https://mb.cision.com/Main/13456/2715933/975197.pdf
Here is the excerpt that has my ire:
With the tentative approval, Brixadi has met all regulatory standards of clinical and non-clinical safety, efficacy and quality for US approval. However, final approval of a monthly depot is according to the FDA subject to the expiration of an exclusivity period granted to Sublocade™. The restriction period may not last longer than November 2020, but both the scope and duration could be reduced if successfully challenged.

This has me frustrated. Sublocade is the inferior product, when compared on paper. I hope this is challenged and they release it stat. Brixadi can quell many of the REMS issues in one fell swoop and have so much greater ease in prescribing than sublocade.

Are you venting about the politics of the situation, or have you actually seen data comparing the two? If so, any chance you could provide those references? I'm not aware of any head-to-head comparisons.

 

[Sushirolls]

Venting about the politics of the delay, for sure.
The comment on superior product is not in context of comparative data, but in real world flexibility of administration and population management.

Sublocade requires patient already be stabilized on oral formulation for a week. And it only comes in a month long formulation. Many patients will not want to switch from oral to injections. Brixadi will be superior in that you can skip this whole issue and simply say you only prescribre brixadi. Most REMS issues disappear with prescribing an injectable. Brixadi, also has flexibility, especially in early stages of stabilization that you can do once week injections with a once weekly formulation, and when appropriate switch to the monthly. This population tends to not return if they don't have to. And a lot can happen in 30 days for relapse.

PROS: weekly formulation, and no oral pre-loading required.

 

[QofQuimica]

Gotcha. Fair enough. It will be interesting to see what happens next year when Brixadi presumably becomes available.