Since 2007 the much anticipated pharmaceutical answer to alcohol flush reaction called Convivia has changed hands like a hot potato. Originally developed by Convivia Inc and later acquired by Raptor Pharmaceutical, the promising yet allusive technology now finds itself in the hands of Horizon Pharma after their acquisition of Raptor Pharmaceutical in October 2016. But all mergers and acquisitions aside, the question we’ve all been asking for the past 10 year remains unanswered – when will Convivia be released to the market?
Unfortunately the answer is unclear to say the least. What we do know is that in 2008 Raptor Pharmaceutical initiated a phase IIa clinical trial for Convivia. Phase IIa clinical studies are aimed at establishing a scientific basis for the efficacy of the drug being tested. In the case of Convivia, it was later that year that they announced positive phase IIa clinical trial results stating that:
The study results demonstrated that the active ingredient in Convivia(TM) significantly reduced heart palpitations (tachycardia), which are commonly experienced by ALDH2 deficient people who drink, at all dose levels tested. The study also found that the 4-MP significantly reduced peak acetaldehyde levels and total acetaldehyde exposure in a subset of the study participants who possess specific genetic variants of the liver ADH and ALDH2 enzymes.
According to these phase IIa results it appears that Convivia was successful reducing acetaldehyde and addressing tachycardia, i.e. the increased heart rate commonly reported by people who suffer from alcohol flush reaction. Whilst this might sound positive at a glance, it is worth noting that they make no mention of its efficacy in addressing the issue of erythema, i.e. the red flushing commonly experienced on the face, neck and upper body.
One possibility for this omission could be the relative ease of measuring a test subject’s heart rate as compared to the degree of blood vessel dilation and resulting redness of their skin. However, another explanation could be that it didn’t reduce acetaldehyde levels enough to have a noteworthy effect on facial and upper body redness – the bottom line is we don’t know.
Despite this, in 2010 Raptor Pharmaceutical announced that it had entered into an exclusive licensing agreement with Uni Pharma Co to commercialise Convivia in Taiwan. In their press release they stated:
Uni Pharma will register Convivia for drug licensure for existing indications and will conduct a clinical trial and register Convivia for acetaldehyde toxicity resulting from ALDH2 deficiency.
7 years later and we haven’t seen Convivia anywhere on the market in the english speaking world, nor do we have any evidence of it being available in Taiwan. One possible explanation could be that it is in fact being sold in Taiwan and we can’t access the online stores due to language barriers. Another explanation could be that Uni Pharma ran into some road blocks, either in the clinical trial stage or with regulatory licensing – again unfortunately we don’t know.
What we do know is that the licensing agreement with Uni Pharma covers solely Taiwan and an option to expand into South Korea under the same terms. What this means is that in the 7 years since the licensing agreement Raptor Pharmaceutical has not progressed the clinical program to Phase III, nor has it made any successful attempts at securing licensing deals outside of Taiwan and South Korea.
With the completed acquisition of Raptor Pharmaceutical by Horizon Pharma, the ball is now in their court as to how they go about bringing Convivia to market in the rest of the world. Do you think Horizon Pharma will look to fast track Convivia in light of it’s huge potential? Or will it get lost amongst all of their other projects for the next 10 years? Only time will tell.
We’d love to hear your thoughts and opinions in the comments below.