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Somaxon Eagerly Awaits (Another) FDA Ruling on Insomnia Drug

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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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10 responses to “Somaxon Eagerly Awaits (Another) FDA Ruling on Insomnia Drug”

  1. John Smith says:

    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.

  2. Jane D says:

    I think John Smith is absolutely right.

  3. 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.

  4. Walter says:

    I fully agree with John Smith, well said.

  5. John Smith says:

    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.

  6. 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.

  7. John Smith says:

    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.

  8. nrb says:

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

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

  10. nrb says:

    take that, moron.