4 ms·

The most amazing part is that this is FDA approved but there was been no efficacy nor safety studies conducted with the exact Bonjesta formulation that is being

The most amazing part is that this is FDA approved but there was been no efficacy nor safety studies conducted with the exact Bonjesta formulation that is being discussed here: > Commentary: There have been no efficacy and safety trials conducted with Bonjesta. A double-blind, randomized, multicenter, placebo-controlled study was conducted to support the safety and efficacy of 10-mg doxylamine succinate and 10-mg pyridoxine hydrochloride tablets (a different formulation and dosage strength) in the treatment of nausea and vomiting during pregnancy. Women 18 years of age or older at seven to 14 weeks gestation (median, nine weeks) with nausea and vomiting were randomized to 14 days of 10-mg doxylamine succinate and 10-mg pyridoxine hydrochloride tablets or placebo. The primary efficacy endpoint was the change from baseline at day 15 in the Pregnancy Unique-Quantification of Emesis (PUQE) score. The PUQE score incorporates the number of daily vomiting episodes, number of daily heaves, and length of daily nausea in hours for an overall score of symptoms rated from 3 (no symptoms) to 15 (most severe). At baseline, the mean PUQE score was 9.0 in the 10-mg doxylamine succinate and 10-mg pyridoxine hydrochloride tablets arm and 8.8 in the placebo arm. There was a 0.7-point mean decrease in nausea and vomiting symptoms from baseline in PUQE score at day 15 with 10-mg doxylamine succinate and 10-mg pyridoxine hydrochloride tablets (95% confidence interval, 0.2–1.2; P = 0.006) compared with placebo. according to this paper: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5215271/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5215271/ Maybe the manufacturer has realized this and is apparently now conducting an actual clinical trial, focusing on adolescents, probably for an expansion of its indication: "A Multicenter Trial of the Efficacy and Safety of Bonjesta® for Nausea and Vomiting of Pregnancy in Pregnant Adolescents" https://clinicaltrials.gov/ct2/show/NCT05289557 https://clinicaltrials.gov/ct2/show/NCT05289557 the FDA is a running joke at this stage. Why would anyone trust that agency is beyond me.

isitmadeofglass 4y ago
> there was been no efficacy nor safety studies conducted with the exact Bonjesta formulation Would you expect this? Not every drug on the market goes through safety and efficacy tests of their exact formulation do they? The point of safety and efficacy testing is to establish that it’s safe and effective, and this can be done in general for a drug, and then múltiple different formularios might enter the market. You don’t redo crash tests of cars because you change the interior lining.
- ekianjo 4y ago
  > Not every drug on the market goes through safety and efficacy tests of their exact formulation do they you are supposed to test the actual formulation in clinical trials, not "some mix that is kind of similar". In safety studies (Phase 1) you can get away with testing something different (i.e. much higher doses) because you want to prove that the drug is safe for use. But Phase 2 is usually where you decide on the final formulation by having several options, and Phase 3 is the final drug tested "as is" before it reaches the market. The formulation is not some kind of cosmetic property, it impacts dissolution speed, bio-availability and many other parameters that can change how the drug works. Some minor adjustments can be made to the formulation between Phase 3 and commercialization but there are strict guidelines on how to justify such changes. In any case, Bonjesta has apparently done no such trials based on the publication referenced. > You don’t redo crash tests of cars because you change the interior lining. Bad analogies are bad analogies.
  - isitmadeofglass 4y ago
    So your arguing that they are illegally marking this despite FDA rules and regulations? Yea, thought not. So we agree that they are following the rules. So this whole “you are supposed to do …” doesn’t really constitute an argument. Also both arguing that the drug is overpriced because it’s just a combination of two other available drugs that you could just buy separately and take together, and then also arguing that they should have conducted a separate tox and efficacy study on the exact formulation they are using is crazy. And you state it yourself in your argument, you are allowed to make changes to the formulation, and not suprimo no Ku they where allowed. And they are not illegally marketing this, so what on earth is your argument?

isitmadeofglass 4y ago

> there was been no efficacy nor safety studies conducted with the exact Bonjesta formulation Would you expect this? Not every drug on the market goes through safety and efficacy tests of their exact formulation do they? The point of safety and efficacy testing is to establish that it’s safe and effective, and this can be done in general for a drug, and then múltiple different formularios might enter the market. You don’t redo crash tests of cars because you change the interior lining.

ekianjo 4y ago
> Not every drug on the market goes through safety and efficacy tests of their exact formulation do they you are supposed to test the actual formulation in clinical trials, not "some mix that is kind of similar". In safety studies (Phase 1) you can get away with testing something different (i.e. much higher doses) because you want to prove that the drug is safe for use. But Phase 2 is usually where you decide on the final formulation by having several options, and Phase 3 is the final drug tested "as is" before it reaches the market. The formulation is not some kind of cosmetic property, it impacts dissolution speed, bio-availability and many other parameters that can change how the drug works. Some minor adjustments can be made to the formulation between Phase 3 and commercialization but there are strict guidelines on how to justify such changes. In any case, Bonjesta has apparently done no such trials based on the publication referenced. > You don’t redo crash tests of cars because you change the interior lining. Bad analogies are bad analogies.
- isitmadeofglass 4y ago
  So your arguing that they are illegally marking this despite FDA rules and regulations? Yea, thought not. So we agree that they are following the rules. So this whole “you are supposed to do …” doesn’t really constitute an argument. Also both arguing that the drug is overpriced because it’s just a combination of two other available drugs that you could just buy separately and take together, and then also arguing that they should have conducted a separate tox and efficacy study on the exact formulation they are using is crazy. And you state it yourself in your argument, you are allowed to make changes to the formulation, and not suprimo no Ku they where allowed. And they are not illegally marketing this, so what on earth is your argument?