Let me get to the point: Somaxon has to go to their excel spreadsheets, rank the patients by ages, isolate the patients who are 65 years or older, check out their sleep times and maintenance at time 0 to month 1, and get their answer. Btw, the company has scrapped sleep latency or time to sleep because it just doesn’t make you fall asleep faster – it just keeps you asleep.

Anyway, back to the analysis: I can do this myself for you in 20 seconds flat, and my rates are low. Odds are, the company did this yesterday and already know what the answer is. No detailed data-mining looking for a nugget, no looking for biomarkers in men between age 30-40 who wear purple shirts on Fridays, no additional trials, none of that stuff. Plain and simple – nothing fancy.

But let’s get to it here, Somaxon said that it will go back and look at the data after the FDA told them they need objective and subjective evidence that its low-dose Doxepin (called Silenor) works in elderly and adult insomnia patients.

Here’s what they said in their press release:

Somaxon plans to conduct additional analyses of its clinical data focused on the durability of subjective sleep maintenance efficacy in adults with primary insomnia. The company will complete these analyses as soon as possible. If the company believes that its additional data analyses demonstrate that Silenor can meet the FDA’s criteria for approvability, it will include the analyses in a resubmission to the FDA.

Don’t keep us in suspense guys — what are you seeing?

Somaxon received a complete response back in February. The FDA at the time it wouldn’t approve the drug without more data, though it didn’t specifically request another trial. It also requested the company address the possibility that Silenor may prolong the cardiac QT interval, slowing a person’s heart rate.

Somaxon was quick, responding in March with clinical trial data that showed Silenor had no effect on QTc interval prolongation when administered at 6 mg, or under exaggerated exposure conditions of 50 mg.

Now the FDA wants objective and subjective evidence of efficacy in adult and elderly patients, something that is required for the label. Was this not discussed before?

Also notice in the press release that the FDA wants “objective and subjective efficacy” in “adult and elderly” patient populations, and efficacy must be shown both at the beginning of treatment and on a persistent basis, defined as at least one month.

Now, Somaxon says their analyzing clinical data focused on “the durability of subjective sleep maintenance efficacy in adults” with primary insomnia.

So what? No elderly? No objective?

So who’s to blame. Is the FDA messing with these guys? In our opinion, no. Management needs to get their stuff together and ask the right questions when they meet with the agency instead of going back and forth and not getting the proper guidance. Get a real team here – FDA is not going to hold your hand. The flip side is that Somaxon knows Silenor is done and they’re just delaying the inevitable – in which case investors are getting screwed – and keep on mining trying to find a way forward.

Somaxon was down about 36% today, 23 cents to close at 40 cents. The company had about $14M in cash at the end of 08 and about $15M in debt. The company failed with Nalmefene for gambling back in 2006, so Silenor with “some efficacy” in “some population” is their last shot.

Iguana thinks: the end is near. To The Graveyard until proven otherwise!

Image from marketsphereus

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