CARDIFF, Calif., Dec. 11, 2012 /PRNewswire/ — NI Research has released the December issue of NeuroPerspective, which features a comprehensive review of pharmacotherapies for depression, with a particular focus upon the programs developing RAADs, rapid-acting antidepressants, an approach that springs from the reports of accelerated depression relief via the use of ketamine.
This 29-page issue includes:
1) An overview of the biology of depression and the implications of accelerated treatment effect for our understanding of depression and pathways for intervention.
2) A review of the many therapeutic strategies that are currently under development, with a special focus upon glutamatergic approaches, those which access the NMDA receptor and associated modulator components. These constitute the pathways for RAADs, where symptom relief may occur in hours, rather than weeks.
Among the programs reviewed, the leaders in the race for a RAAD include:
Naurex, whose Phase IIa data for IV GLYX-13 was just released. In spite of the fact that this was a 116pt dose-ranging study in TRD patients, limited by the small cohort sizes for each of the active treatment groups, GLYX-13 exceeded expectations. Most importantly, none of the doses produced psychotomimetic effects in any patients. The pilot study now requires confirmation from the multiple-dose PhIIb trial underway.
Various Ketamine and Ketamine-combination drugs: These programs are hoping to skirt the risk of psychotomimesis via a variety of tactics. Programs in this vein are underway at JNJ/Addex, Lilly, AstraZeneca, Washington University, Yale, and Mt. Sinai.
AstraZeneca's IV AZD6765 has been tested more extensively than most of its competitors, but it is relatively slow to achieve therapeutic effect, and psychotomimetic concerns are not completely alleviated.
Naurex has an orally bioavailable version of GLYX-13, NRX-1074, approaching IND-readiness. If it emulates GLYX-13's impact and safety, NRX-1074 would widen the scope of Naurex's market across the full range of depression. In terms of other oral glutamatergic options, companies involved in this area include: NeurOp/Bristol Myers Squibb, Lilly, Roche, BrainCells, and Vanderbilt University.
Alkermes' ALKS5461 program has the burden of its opioid legacy, which would almost certainly result in Schedule II placement, and what may be some initial euphoric/intoxicant effects.
Other depression programs of note include:
Vortioxetine, the triple amine reuptake inhibitor from Lundbeck/Takeda, in NDA-preparation, and Euthymics Bioscience with its triple amine drug, amitifadine. Forest/Pierre Fabre's levomilnacipran is having its NDA prepared. Methylation Sciences is developing a reformulation of SAMe that they believe has much better bioavailability. This could be of interest to patients and prescribers who would perceive it as less "drug," more "nutriceutical."
3) Other neurotherapeutic stories of note in the December issue include:
The successful Phase III results for Acadia Pharmaceuticals' pimavanserin.
An illuminating graphic comparison of the six-month efficacy results for EnVivo's EVP-6124 and Lilly's solanezumab.
About NI Research
NI Research is the leading publisher of independent research on the neurotherapeutics industry, and has developed an unmatched information base regarding both publicly and privately held CNS companies. NeuroPerspective (formerly NeuroInvestment) is the authoritative, independent, monthly review of the neurotherapeutics area, providing critical analysis of therapeutics-in-development.
A one-year subscription to NeuroPerspective is $2,300. The December issue of NeuroPerspective is available for $300 as a single-issue purchase.
NI Research also publishes NeuroLicensing, the Private CNS Company Review, and NeuroSynopsis, a monthly four-page summary of highlights from NeuroPerspective. NIR also provides consulting services to the pharma industry regarding licensing and strategic planning.
Further information and online purchasing with immediate delivery are available at http://www.niresearch.com/onlinestore.html