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It is unfortunate that Zyprexa LAI, met with a Non-Approvable Letter, based on a case of delayed sedation reported by Lilly. However, I would not count this medication out and it would be unfortunate if this were the case. Several factors argue in favor of eventual approval.
Over the last few years there have been various "studies" attempting to prove the thesis that antidepessant medications (SSRI's are usually the focus) are little better than placebos. This latest salvo will be a very minor blip, not a speed bump.
Excitement is brewing among the cognoscenti around a new paradigm to treat mental illness, schizophrenia in particular. The buzzword is glutamate...and early studies show promise...but will the huge investment of resources prove ultimately profitable.
Congress is considering legislation to place mental illness on the same footing as other medical disorders. The parity bills being considered by the House and Senate differ widely in scope. The resulting legislation will likely affect the insurance coverage of millions of people for many...
1. Controlled release preparations are often better tolerated with fewer side effects than immediate release preparations 2. OCD and SAD are severe, highly prevalent and chronically disabling conditions 3. Despite presence of SSRIs and other treatment, e.g, cognitive behavioral therapy, up to 1/3 of...
1. Despite common use of multiple psychotropic medications for bipolar disorder in youth, there are few FDA-approved treatments 2. Abilify is one of the safest and best tolerated of the atypical antipsychotics with fewer side effects than some of the other atypical antipsychotic medications 3. This...
Triple-reuptake inhibitors (TRIs) represent an emerging class of antidepressant drugs in development with potential application for other disorders including ADHD and obesity. By potentiating all three of the main monoamine neurotransmitters implicated in depression - serotonin, norepinephrine,...
Luvox was one of the first SSRI's approved for pediatric prescription (for OCD rather than for depression). When patent expired, the maker discontinued manufacture. It has been available in limited supply as generic. Availability of brand-name extended-release product (Luvox CR) will be a significant...
The use of a monoamine oxidase inhibitor (MAO-B) inhibitor for smoking cessation represents a novel strategy for this indication that may ultimately compliment most existing strategies (e.g. nicotine gums, patches). However, proving the utility of treating tobacco dependence by inhibiting the...
Fluovoxamine is perhaps the last participant in the SSRI explosion of the 1980's. It is also the least used and hence, least profitable entry in the SSRI horse race, primarily because of timing rather than any particular pharmacological deficiency. To believe that this attempt to rejuvenate...