The Expertise Imperative and Compliance Technology
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Abbott’s Neuronal Nicotinic Receptor (NNR) partial agonist platform is an innovative target for ADHD and potentially other CNS disorders. The Phase II data on ABT-089 suggests efficacy for adult ADHD with good safety/tolerability. NNRs will not have the kind of effect size seen with stimulants...
Eli Lilly needs to find a compelling niche for Strattera since, in the treatment of ADHD, it is viewed as a less effective, though safer (because it cannot be abused), alternative to stimulants.
My personal prediction is that this product will NOT be on the market in 3-5 years. My clinical experience never approached that which the research would suggest. I suspect that the "research" that was done on this product is frought with company incentives.
1. Effective treatment for ADHD 2. Well tolerated with few side effects 3. Help with smoking, a big problem in ADHD patients important 4. Advantage in not being Schedule II may be helpful
1. Important new finding given safety concerns raised about this and other treatmetns 2. Nice to have data back up what has long been done clinically 3. Stimulants still first line and lack of active comparator trial
Sometimes what appears to be an obstacle in the path to drug development has the opposite effect. In the case of the FDA's response to Mipomersen this may well be the case...and it may be the harbinger of a more "collaborative" approach by the FDA.
Alnylam (Nasdaq: ALNY) has hit upon a novel concept (in collaboration with MIT) in enabling RNAi therapeutics to reach their intended targets. Look for an explosion of applications.
The USPTO’s proposed rule changes, struck down in this important Glaxo federal court decision, would have added significant burdens to pharmaceutical companies in developing their IP portfolios and ultimately their drug treatments. The proposed changes were seemingly motivated to make the...