GLG News by Dr. David Rosenberg MD, Chief of Psychiatry and Psychology
GLG News is now G+ Insights
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Neuronal nicotinic receptor agonists potential breakthrough for ADHD research
May 12, 2008
Abbott Scientists Present A New Approach for Treating Attention-Deficit Hyperactivity Disorder | biz.yahoo.com
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
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Important New Data for Children and Adolescents
May 12, 2008
FDA Approves Strattera® for Maintenance of ADHD in Children and Adolescents | newsroom.lilly.com
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
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Exciting new treatment for OCD and Social Anxiety Disorder
March 7, 2008
FDA Approves Luvox CR (Fluvoxamine Maleate) Extended-Release Capsules for the Treatment of Social Anxiety Disorder and Obsessive Compulsive Disorder | pharmalive.com
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 patients with OCD or SAD do not respond to currently available treatments and among responders many do so only partially
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FDA Approval of Abilify for Pediatric Bipolar disorder is a Major Advance
March 7, 2008
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 treatment offers new hope to many children and their families
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More questions raised than answers
February 5, 2008
Chantix And Suicide: The Latest Numbers | www.pharmalot.com
No good data that Chantix is associated with suicide Need more controlled research to answer questions Scary adverse events are not the same as side effects directly linked to medication
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Pediatric Bipolar Disorder is an Urgent Public Health Problem
September 5, 2007
Bipolar Disorder Among Kids in U.S. Rising, Study Suggests | online.wsj.com
1. Pediatric bipolar disorder is an urgent public health problem 2. There is added recognition that this can occur in children 3. Very difficult to diagnose-need comprehensive assessment to ensure accurate diagnosis and as importantly not 'overdiagnosing'
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BL-1020 the First Novel Antipsychotic in Quite a While
August 23, 2007
BIOLINERX STARTS PHASE II TRIAL OF BL-1020 FOR SCHIZOPHRENIA. | www.therapeuticsdaily.com
1. BL-1020 represents an important advance from Israel's top drug development company 2. Unique mechanism without Parkinsonian side effects or cardiovascular, metabolic, weight gain (from atypical antipsychotics 3. This may enhance treatment adherence with better outcomes 4. Likely will be useful for various other conditions, e.g, other psychoses, bipolar disorder, mood disorders, etc
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Abilify is Go to Drug for Adjunctive treatment for Depression
August 9, 2007
ABILIFY(R) (aripiprazole) Supplemental New Drug Application Receives Priority Review by U.S. Food And Drug Administration for Adjunctive Treatment in Adults With Major Depressive Disorder | www.pipelinereview.com
1) Because of its excellent safety profile, enhanced side effect profile (e.g, weight gain, carbohydrate metabolism abnormalities) compared to other atypical antipsychotics such as risperdol, zyprexa and seroquel, this is an exciting 'go-to' medication 2) Best for augmentation, and one of our go-to medications for patients with both unipolar/major depression and bipolar disorder 3) Low dose augmentation is typically best which further enhances treatment response without problematic side effects
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Key Determinant which treatment works best for which particular patient
July 24, 2007
Studies Track Treatment Outcomes for Kids With ADHD | www.forbes.com
1. These are landmark studies helping us better understand the long-term outcome of children with ADHD 2. Recognize that even with treatment the symptoms do not go away 3. Have to take a medical approach analogous to other medical conditions, e.g, diabetes where biologic intervention (e.g, insulin) and psychosocial intervention (diet and excercise)
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More questions than answers raised by this report
July 24, 2007
UK Regulator: 1 Person in 10 on Acomplia Experiences Psychiatric Side Effects | www.acompliareport.com
1. These type of reports can be concerning but are countered by rates of 'psychiatric events/reactions' in the general community. 2. There are key questions, e.g, how many dieters had diagnosed (or undiagnosed) psychiatric conditions? 3. Tougher warnings can be good if it warns physicians and patients that medications are never magic bullets and there can be side effects with any medication
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Very exciting new lead in ADHD research
July 12, 2007
Shire Receives Approvable Letter from FDA for INTUNIV(TM) (guanfacine) Extended Release, a Nonstimulant for the Treatment of ADHD | www.pipelinereview.com
1. While 70% of ADHD patients respond to stimulants and Strattera, 30% do not; thus, a large population who need new treatment approaches 2. Extended release preparation offers significant advantages 3. This medication has shown some efficacy in controlled study with tics/tourettes-often comorbid with ADHD and has safety profile far superior to clonidine
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July 12, 2007
INVEGA(TM) Receives Marketing Authorization In European Union For Treatment Of Schizophrenia | www.pipelinereview.com
1. Need for active comparator clinical trials, e.g, comparing medication not just to placebo but to risperidone and olanzapine acutely and short-term 2. Advantages of extended release preparations include less daily fluctuation in in drug concentration (peak to trough) so patients may spend more time every day above the minimal therapeutic effective concentration 3. Extended release had favorable side effect profile and may allow in more chronic treatment for better tolerability and ability to increase dose; however, acutely, may not offer advantage over risperidone (active trials needed)
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Alzheimer's Drug Patch Important Advance
July 12, 2007
UPDATE: Novartis Wins FDA OK For Alzheimer's Drug Patch | money.cnn.com
1. Will faciltiate compliance and administration of medication 2. May have fewer drug-drug interactions 3. History for other conditions, e.g, hypertension (clonidine), ADHD (Daytrona) suggests value
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Once daily Welbutrin XL represents a significant advance
July 12, 2007
Once-daily Wellbutrin XL | www.ncbi.nlm.nih.gov
1. XL preparation better tolerated 2. Facilitates better compliance and adherence to treatment than twice daily medication 3. Able to give higher dose early, better compliance likely result in fewer side effects, more rapid onset of antidepressant effect
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Vyvanse-an important new medication but not the holy grail for ADHD
June 28, 2007
Shire showcases new drug Vyvanse to wary doctors | investing.reuters.co.uk
1. While 70% of patients respond to available ADHD treatments, 30% do not so need for new treatments important 2. Lowering risk of abuse very important and attractive 3. Since same category of drugs as other stimulants not likely to appeal to clinicians who prefer prescribing non-stimulant, FDA-approved medications such as Strattera which is far easier to prescribe/can call in prescriptions, etc. 4. Not FDA approved for use in adults with ADHD which is the largest growing population being treated by Concerta/other stimulant medications
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Nuvigil may have major advantages compared to Provigil
June 21, 2007
Cephalon Receives FDA Approval of NUVIGIL(TM) for the Treatment of Excessive Sleepiness Associated with Three Disorders | www.pipelinereview.com
1. Nuvigil may have fewer side effects than Provigil 2. Nuvigil may have more rapid onset than Provigil 3. May have broader clinical applications, e.g, depression, anxiety, bipolar disorder, ADHD (adult and child), schizophrenia, etc
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New biomarkers for psychiatric disorders
June 11, 2007
Aspect Medical Systems' psych treatment | biotech.seekingalpha.com
This is new era of biological psychiatry Modern technology including EEG, MRI, pharmacogenetics can help us not only better diagnose subtypes of mental illness but have potential to help predict treatment response (or lack, thereof) Having relevant biomarkers predictive of treatment response (or lack thereof) is critical in psychiatry At present, all are research tools and none equivalent or as good as good comprehensive psychiatric clinical assessment
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Plans focusing on Wellness all too often forget mental health
April 30, 2007
Employers' plans emphasize wellness | www.pennlive.com
Mental health problems are associated with more physical problems
Mental health problems such as depression associated with more occupational problems, days off, etc -
Proper Pharmacologic Treatment of ADHD reduces risk of substance abuse
April 30, 2007
A New Look at the Relationship and Management of ADHD and Comorbid Substance Use Disorder | cmsprepub.medscape.com
Treating ADHD reduces risk of comorbid substance abuse with appropriate doses of medication
Untreated ADHD and substance abuse increases risk for dependence, adverse outcome including jail, sociopathy, adverse impact on occupational, social and personal functioning -
April 30, 2007
Caraco Pharmaceutical Laboratories Ltd. Announces FDA Approval To Market Generic Ambien(R) | www.medicalnewstoday.com
Urgent need for generic
Proprietary medications often prohibitively expensive
Insurance plans often prefer generic equivalents
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