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Somaxon Eagerly Awaits (Another) FDA Ruling on Insomnia Drug

Xconomy San Diego — 

[Updated: 11:45 am Eastern, 3/17/10] Who was it that once said ‘if at first you don’t succeed, try, try again?’ This Friday, San Diego-based Somaxon expects find out from the FDA whether its persistence has paid off, and whether its insomnia drug is finally ready to be cleared for sale on the U.S. market.

The FDA has a deadline of Sunday, March 21 to complete its review of Somaxon’s application to market doxepin (Silenor) to help people get a better night’s sleep. Since the statutory deadline falls on a weekend, it’s likely the FDA will send its letter to the company before the end of the day Friday. For all you antsy traders out there, it’s entirely possible investors will have to wait until Monday to hear the news (but please don’t call to ask me to speculate on the exact timing).

It’s hard to imagine Somaxon (NASDAQ: SOMX) has much steam left in its engine, but it’s still in business while awaiting this latest FDA ruling. The company’s application was delayed in November 2008, formally shot down in February 2009, and rejected one more time in December. Somaxon has burned through more than $176 million of investors’ money since it was founded in 2003, and had just $5.4 million left in cash and investments as of its most recent quarterly report, current through September 30. Still, investors haven’t given up all hope—the company’s stock has rebounded after the FDA setback in December, boosting the company’s stock to $4.05 at yesterday’s close.

I have to say this optimism struck me as kind of odd, given what the company itself said in its quarterly report about its regulatory dealings.

“The regulatory approval process is inherently complex, and clinical and non-clinical data is subject to varying interpretations. As a result, as of September 30, 2009, the Company does not consider FDA approval of the NDA for Silenor to be probable in accordance with the criteria used for accounting purposes,” the company said.

[Updated with comment from sleep researcher.] Somaxon declined a request to comment on why it thinks Silenor deserves a place on the market. But Dr. Thomas Roth, a sleep researcher at Henry Ford Hospital in Detroit and a consultant to Somaxon, explained why he considers the drug an intriguing option for patients.

“If one looks at the control of sleep,” Roth says, “there are transmitters to drive sleep (EG GABA) and there are transmitters which drive wakefulness like histamine, orexin, and seratonin. Antagonists to these systems produce sleep. However, this is different than working on sleep systems. For example, if you look at Silenor, there is data to show that it improves sleep in the last two hours of the night without impairing alertness the next days. Drugs working on Gaba do not have that combination. I think this medication will benefit patients who have difficulty with staying asleep during the night.”

Still, Roth was careful to point out that he hasn’t reviewed the whole drug application like the FDA has.

As a reminder, here’s some of the quick facts on the Silenor application. The company hopes to compete a crowded marketplace with brands like Sanofi-Aventis’ zolpidem (Ambien and Ambien CR), King Pharmaceuticals’ zaleplon (Sonata), Dainippon Sumitomo’s eszopiclone (Lunesta), and Takeda Pharmaceuticals’ ramelteon (Rozerem).

Somaxon says its drug is different from the others, in that it is designed to block histamine, a neurotransmitter in the brain that’s believed to help keep people awake. Clinical trials to date have shown that the drug can help people get a full night’s sleep including sleep into the 7th and 8th hour, the company says.

The FDA, back in February 2009, told Somaxon there didn’t appear to be any adverse events that would stand in the way of the drug getting approved. But the agency did question how the company interpreted data on the drug’s effectiveness.

In April, the FDA told Somaxon that if it were going to get the green light for an insomnia drug—which could be used chronically by millions of people without a life-threatening condition—-then “objective and subjective efficacy must be established in both adult and elderly patient populations, and efficacy must be shown both at the beginning of treatment and on a persistent basis, defined to be at least one month,” the company said in its quarterly report.

Somaxon went back to re-analyze some of its clinical trials, to respond to the FDA’s input. Whether this passes muster with the FDA, we’ll find out soon. Maybe Friday. Maybe Monday.

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  • John Smith

    Sir – did you review the January 21 response from the FDA? This is a Class I resubmission. Aside from the fact that Class I resubmissions receive approval 90% of the time, clearly Somaxon addressed the efficacy issues with the FDA in their discussions with them, as no additional trials were mandated.

    As to your reference to the company’s statement about not being able to factor Silenor’s approval for accounting purposes, this is a standard disclaimer. Of course Somaxon cannot factor this in until it is approved.

    Quite frankly I view your article as biased against Somaxon. You only presented the negatives and did not point out the fact that this is a Class I resubmission, and you deliberately spun a standard disclaimer as a negative.

  • Jane D

    I think John Smith is absolutely right.

  • John–I saw that press release on January 21. I’ve not seen any data that says Class I resubmissions get approved 90 percent of the time. The FDA also said it still had an issue with part of the application on the drug’s efficacy.

  • Walter

    I fully agree with John Smith, well said.

  • John Smith

    Luke – the 90% number can be derived from looking at past Class I resubmissions.

    I know the FDA had issues with the efficacy; they addressed this in the CRL. However, one has to assume that Somaxon addressed these with them at the meeting with the FDA in January and updated their package accordingly; otherwise they would simply be replaying the same tune as back in December.

    Do you really think Somaxon is desperate or foolish enough to simply resubmit the same data that earned them the CRL in December?

    Looking forward to your reply.

  • John—I don’t mean to say Somaxon is foolish, but they don’t really have any options besides Silenor. Sure, they probably did what the FDA asked them to do. But that doesn’t mean FDA can’t find another reason to hold the application up. Look at what happened to Xenoport.

  • John Smith

    Luke – agreed that you never know with the FDA; however, Xenoport was denied because of Pancreatic Cancer risk, not efficacy issues. Not an apples to apples comparison.

    Bottom line is that Somaxon was asked to address efficacy issues relating to patients of all ages. In their meeting with the FDA in January, I am sure this was discussed and addressed. Logic dictates that Somaxon then formally addressed these efficacy issues in the resubmission package.

    Overall I give this 90%+ chance of approval. The 10% only being due to the finicky nature of the FDA.

    If you hear from Dr. Roth, please update your article with his comments.

  • nrb

    I also agree fully with John Smith.
    You might want to hire a copy editor too.

  • I just updated the story with a comment from Dr. Roth.

  • nrb

    take that, moron.