Serada™, in actual fact, is an investigational formulation of another drug – Gabapentin (Neurontin), an FDA-approved immediate release pharmaceutical – originally developed for the treatment of epilepsy and currently also used to relieve neuropathic pain and vasomotor symptoms (hot flashes) associated with menopause and in women with breast cancer.
What is novel about Serada™ is that it is an Acuform™-enhanced formulation – an extended release version of Gabapentin. Acuform™ delivery technology is Depomed’s unique, patented, polymer-based technology designed to optimize drug delivery. Time release formulas, including extended release types, are specially designed versions of a drug that delay the release of the active ingredient such that it is absorbed by the body over a given period of time. A drug of this formula may have effects that last until the next dosage is taken which can be important in situations in which the medication is designed to alleviate pain for example or halt unpleasant side effects such as is would be the case of hot flashes in menopausal women.
Often these medications sustain desired levels in the bloodstream rather than administering an initial spike with decreasing integrity. Formulated with the Acuform™ drug delivery technology, Serada™ has the promise of both efficacy and fewer side effects commonly observed with the immediate-release formulations of Gabapentin, including dizziness and daytime sleepiness.
Low-dose mesylate salt of paroxetine (LDMP) is a selective serotonin reuptake inhibitor (SSRI) with a chemical structure related to paroxetine hydrochloride (brand name Paxil), with lower doses of paroxetine vs. doses prescribed for psychiatric disorders (i.e. those < 20 mg per day). The use of off-label anti-depressants – for example, paroxitine (Paxil), venlafaxine (Effexor), fluoxetine (Prozac) and sertraline (Zoloft) – to offer some relief of vasomotor symptoms associated with menopause is not new.
SSRIs affect the brain’s use of serotonin, a neurotransmitter, which is believed to play a role in regulating body heat. Purportedly LDMP is unique in that the dosage is 25% less (10 mg) than off-label anti-depressants used to treat psychiatric disorders together with “finding the right dose of the right drug, with an acceptable side effect profile” which to date has not been an easy task.
Clearly a market for Serada™ and LDMP exists as these non-hormonal drugs have the potential to provide women suffering from menopausal hot flashes with new and alternative treatments – options that have more favorable safety profiles than that of conventional HRT containing Conjugated Equine Estrogens (CEE’s) and without exploitation of the mares and their foals.
GOOD NEWS SHORT-LIVED
The good news however was short-lived.
On March 4, 2013, the US Food and Drug Administration (FDA) Reproductive Health Drugs Advisory Committee voted that the overall risk/benefit profiles of both Serada and LDMP are not acceptable to support approval.
In the case of LDMP the committee voted 7 to 7 that it was effective in treating moderate to severe VMS (vasomotor symptoms) associated with menopause however 10 to 4 that there was not sufficient evidence of its effectiveness to decrease the frequency of VMS events.
Serada fared much worse and was overwhelmingly rejected by the committee both for its risk benefit in treating VMS (12 to 2) and efficacy (13 to 1).
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