Richard Pascoe, chief executive of Somaxon Pharmaceuticals (SOMX-$1.10), expressed confidence that the resubmitted New Drug Application of Silenor (doxepin) for insomnia in adults will address the FDA’s concerns about the drug's sleep maintenance efficacy and cardiac safety profile (risk of ventricular arrhythmias). Irrespective of a favorable approval, the commercial success of Silenor is far from a certainty.
It will take at least six-months for the FDA to complete its review—and the marketing window for Silenor is closing quickly, with the in-licensed patent for the treatment of chronic insomnia (when the inability to fall asleep last for more than three weeks) scheduled to expire in March 2013. In addition, although the company claims that Silenor’s selective histamine H-1 blockade – and lack of specificity for re-uptake at other central nervous system target sites – makes the drug a good candidate for insomnia, it is unlikely that mechanism of action alone will be enough to convince physicians to switch from better established sleep hypnotics, which include Lunesta (eszopiclone), Ambien CR (and its generic zolpidem), and Restoril (and its generic temazepam).
Somaxon is running out of cash, and is expected to announce a highly dilutive capital offering by the end of July (likely stock-warrant units). Management has yet to formalize a strategic partnership with a pharmaceutical company that already has established access to the highest prescribing physicians of insomnia treatments, too. The longer it takes the company to announce a strategic deal, the less income it is likely to keep in a royalty-sharing arrangement.
It’s a common myth that your sleep quality decreases as you age. Existing Somaxon shareholders, however, have plenty of worries to keep them up at night.
Editor David J Phillips does not hold a financial interest in any stocks mentioned in this article. The 10Q Detective has a Full Disclosure Policy.
The National Sleep Foundation show's the data and effects of Insomnia. Also Ambien has EKG side effects and Silenor does Not. (Google Ambien and EKG)
ReplyDeleteFrom National Sleep Foundation
About Insomnia
Approximately 70 million American adults are affected by insomnia – characterized by difficulty falling asleep, waking frequently during the night, waking too early and not being able to return to sleep, or waking up not feeling refreshed.
Results from a 2005 National Sleep Foundation Sleep in America poll reported that respondents experienced the following insomnia symptoms:
•54% experience insomnia symptoms every night or a few nights a week,
•32% awake often during the night (sleep maintenance),
•21% wake up too early and cannot get back to sleep (premature final awakening), and
•21% have difficulty falling asleep (sleep onset).
Studies estimate that 20% to 40% of all adults complain of acute, or transient, insomnia, generally defined as a complaint lasting several days up to a couple of weeks, while 10% to 15% complain of chronic insomnia, generally defined as a complaint lasting approximately four weeks or longer.
The negative health consequences of insomnia are becoming better understood. Studies have shown that insomnia lasting more than four weeks is associated with a wide range of adverse conditions, including mood disturbances, depression, difficulties with concentration and memory, and certain cardiovascular, pulmonary and gastrointestinal disorders. Chronic sleep deprivation has also been associated with an increased risk of diabetes and obesity. One study showed that when normal sleep was restricted by as little as two hours per night across two weeks, the affected person experienced a significant decrease in cognitive function that resulted in reaction time and other performance measures resembling those of a person who stayed up for 48 hours straight.
The Patent Info from the company website.
ReplyDeleteIt goes thru 2020 not 2013
http://www.somaxon.com/pages/ab_bizDev.htm
Comprehensive IP Protection
· Patent protected for use in insomnia through 2020.
· Formulation exclusivity with patent protected key excipient.
· Multiple new patent applications related to formulation and label.
· Next generation product in development.
The float is 18.4M and very small of which insiders own 4M.
ReplyDeleteHighly Dilutive is ridiculous with such a small float.
The Patent Expires 2020 not 2013.
ReplyDeletehttp://www.somaxon.com/pages/ab_bizDev.htm
Patent protected for use in insomnia through 2020.
· Formulation exclusivity with patent protected key excipient.
· Multiple new patent applications related to formulation and label.
· Next generation product in development.
Why do you not report the facts?
ReplyDeletePatent expires 2020!
Read the 'fine print' folks. FIRST complex compound patent expiry is in 2013 -- which is all generic pharma companies pursuing aggressive new "at-risk" launch ventures need to flood the market with me-too, cheaper pills!
ReplyDeleteWhy not supply a link for your read the fine print. Your talking about all generics not specifically Silenor.
ReplyDeleteSecond Silenor isn't a generic to Ambien Lunesta, etc as they target different receptor cells. Silenor targets H1 receptor cells and is an alternative to the side effects caused by GABA receptor cells.
http://www.somaxon.com/pages/silenor.htm
The leading approved insomnia medications, Ambien®, Ambien CR®, Sonata® and Lunesta®, work by binding to and activating a different set of brain receptors known as GABA receptors. These products induce sleep by non-selectively suppressing the CNS arousal mechanism and are associated with numerous undesirable side effects such as hallucinations, amnesia, complex sleep behaviors (e.g., sleep driving, sleep eating) and the risk that these medications are habit forming. Because they carry a risk of dependency, they are designated by the DEA as Schedule IV controlled substances, which require additional registration and administrative controls. These products tend to be effective at inducing sleep, but continued non-selective suppression of the arousal system upon awaking will likely result in residual sedation, a side effect that is viewed negatively by the overwhelming majority of patients. As a result, these products are designed so that their effects can be expected to wear off prior to the end of the night.
EatonRush:
ReplyDeleteNo disrespect intended -- but, do you really think physicians {in the trenches) who do the bulk of prescribing really care about mechanisms of action?
No Disrespect but the side effects of Lunesta , Ambien , etc. aren't tolerable by the patient nor wanted than physicians can issue an alternative therapy . Yes, if you have a good physician they will care about the side effects and delivery method.
ReplyDeleteAmbien is a great drug and most patients tolerate it very well. IF that wasnt true, it would have never been a $2B drug.
ReplyDelete