Trevena (TRVN) and AcelRx (ACRX) have back-to-back adcoms this week for their pain medications. However, their two meds are quite different from each other, and it will be a mistake to base ACRX investment decisions on the fate of Trevena. We need to wait for ACRX’s own briefing docs, which should be released today. From what we have heard so far, ACRX does seem to have a decent chance at success.
Trevena's briefing docs have been released, and the stock is cut to size almost by half because the market believes the briefing docs are negative. If the briefing docs from the FDA are negative, there's a huge probability that the adcom will be negative, especially for an opioid drug that people will fear to back because of the so-called opioid crisis politics. Hence, the adcom will be negative. In more than 90% of cases where the adcom is negative, the PDUFA is negative. So, Trevena's drug is going to be rejected.
Specifically, the FDA believes that oliceridine has high abuse potential. Further, the FDA believes that at least one dosage of oliceridine "looks slightly less efficacious" than morphine but has similar negative safety profile. That kind of kills it for oliceridine. In private comments in TPT chat room around October, I sort of said the same thing - the efficacy-vs.-safety profile was underwhelming for oliceridine.
When we compare the situation of oliceridine with ACRX's DSUVIA - briefing docs will probably be released by the time this is published - we note a number of differences. First, DSUVIA is already approved in the EU, if that matters. Two, DSUVIA has already gone through a CRL, where efficacy was never in doubt, nor safety. The FDA asked for a very different kind of data in that CRL that was more abuse-related than anything else. The abuse concern is going to be a common thing for all these drugs - it is not going to go away.
Why did the FDA want an adcom suddenly, after only announcing a PDUFA? It seems that the question of abuse is a matter of opinion, and not a scientific analysis; hence, the FDA wanted KOL opinions. The FDA, basically, wanted to see which way the wind was blowing, and the best way to do that is an adcom. It seems to me that they are okay with the safety-efficacy question of what is, after all, a drug which has seen very successful trials. The FDA just wants to see about the abuse thing.
Therefore, the ACRX adcom is all about expert public opinion on the abuse question. Unlike Trevena's adcom, this has nothing to do with efficacy or safety. And that is the precise difference between the two.
I have had a lot of success in trading ACRX over the years. So I am happy to hold on to it for one last time at sub-$3 prices. I am hoping it will not let me down this time; it never has before. We will see.
Ritter Pharma up 11% premarket on RP-G28 data
Ritter Pharma (RTTR) published positive new data from a mid-stage phase 2b study of RP-G28 in patients with lactose intolerance. There was significant increase in several types of bacteria that help lactose metabolism after patients received the drug. "Specifically, bifidobacteria increased 77.7% in the treatment groups who experienced improved lactose tolerance and increased milk consumption two times 30 days after treatment." The drug is designed to stimulate growth of such bacteria in the gut. Lactose intolerance is widespread in those areas of the world where people have better access to sunlight. However, immigrants from such countries to the US are also susceptible to lactose intolerance as an inherited health issue.
Selected other news:
Disclosure: I am/we are long ACRX. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
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