CARDIFF, Calif., May 6, 2014 /PRNewswire/ — NI Research has released the May issue of NeuroPerspective, which features a comprehensive review of pharmacotherapies for depression, with a particular focus upon the companies developing RAADs, rapid-acting antidepressants, an approach that springs from the reports of accelerated depression relief via the use of ketamine, and has been further invigorated by the success of Naurex's GlyX-13 in clinical testing.
As NeuroPerspective publisher Harry Tracy notes: "The successful development of rapid-acting antidepressants will constitute a true 'game-changer' for the depression field, as the pharma industry will then have the opportunity to make a prodigal return, to reassert itself in a domain that in recent years has been ceded to generic antidepressants."
This 34-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, that access the NMDA receptor and associated modulator components. These constitute the pathways for most RAAD candidates, 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 IIb data for IV GLYX-13 was just released. GlyX-13 produced rapid antidepressant effect that was sustained with repeat administrations. No psychotomimetic effects were seen. While Naurex has only released top-line results, the fact that their investors responded with another $25 million in funding speaks volumes.
Naurex also has an orally bioavailable version of GLYX-13, NRX-1074, that has entered Phase II. If it emulates GLYX-13's impact and safety, NRX-1074 would widen the scope of Naurex's potential market across the full range of depressive disorders.
Various ketamine and esketamine programs: These programs aim to skirt the risk of psychotomimesis via a variety of tactics. Programs in this vein are underway at JNJ/Janssen, Washington University, Yale, and Mt. Sinai.
NR2B receptor subtype modulation is another highly promising glutamatergic approach. Cerecor is already in Phase II with a drug licensed from Merck: BioCrea, Mnemosyne, SAGE, and NeurOp have preclinical programs using this mechanism.
MGluR targeting has potential in depression, Roche has two promising programs therein.
Alkermes' ALKS5461 program has the burden of its opioid receptor targeting, which, even if it successfully acts via the kappa opioid system to provide antidepressant effects, means that it comes with opioid-type side effects. But this drug is in a highly ambitious Phase III program, Alkermes hopes that careful dose-titration may yield an acceptable side effect profile.
Additional depression programs of note covered in this review include:
Brintellix/vortioxetine, the new antidepressant being launched by Lundbeck/Takeda, now must show in real-world use whether its expected positive effects on cognition, and better side effect profile in terms of sexual side effects, pan out in real-world use.
Methylation Sciences is in Phase II with 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.'
Other depression programs discussed in the May overview include those from NeuralStem, Tetra Discovery, Pherin, andMinerva Neuroscience, as well as the growing field of 'electroceuticals', particularly the burgeoning use of TMS for depression.
Other stories of note in the May issue include:
- Critical commentary regarding the risks attached to exorbitant pricing for new pharmaceuticals, with Gilead and Vandaproviding the most recent examples.
- Commentary regarding the folly of consolidation in the pharma industry, a process that is guaranteed to drain expertise and creativity from an industry that needs both. Valeant and Allergan, Pfizer and AstraZeneca, are the players currently center-stage.
- Strong clinical data for Civitas Therapeutics; implications of Bristol Myers Squibb's acquisition of tau companyiPierian.
- The issue also includes an overview of BioCrea in the Company Spotlight section.
NeuroPerspective is the authoritative, independent, monthly review of the neurotherapeutics area, providing critical analyses of therapeutic programs-in-development. Recent issues have reviewed the areas of Multiple Sclerosis, Innovation in Neurotherapeutics, Huntington's, and Migraine.
A one-year subscription to NeuroPerspective is $2390. Nonprofit and academic pricing is available. The Depression Issue is being made available as a single-issue purchase, for $250.
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