President, RED OAK PSYCHIATRY ASSOCIATES, P. A.
Member of the Healthcare Council
Lawrence Ginsberg, MD, is President and CEO of Red Oak Psychiatry Associates, PA, a multidisciplinary mental health group in Houston, Texas. Dr. Ginsberg's research interests include psychopharmacology, addiction medicine, and forensic psychiatry. His areas of clinical expertise are attention deficit hyperactivity disorder (ADHD) and bipolar disorder in both children and adults, as well as generalized anxiety disorder and panic disorders. Dr. Ginsberg consults for over 20 pharmaceutical companies and has been an investigator on numerous drug trials for anxiety, bipolar disorder, and ADHD. (This is me - Update Profile)
Opinions and analyses expressed in GLG News are solely those of the author. See the Terms of Use for details.
Vanda"s Iloperidone: Lemonade or Lemon
October 11, 2007
Vanda Pharmaceuticals Submits Iloperidone New Drug Application | www.pipelinereview.com
1. Iloperidone has demonstrated efficacy in treating positive and negative symptoms of schizophrenia and also has a favorable safety profile. 2. Vanda has utilized pharmacogenetic studies to identify a group of schizophrenic patients that will benefit from this agent that binds to a number of serotonin and dopamine receptors. 3. Two out of three previous Novartis Iloperidone trials were failed trials but they utilized low to medium doses of Iloperidone.
DOV 21,947: A Triple Reuptake Inhibitor With a Favorable Metabolic Profile
October 8, 2007
DOV 21,947 Demonstrates Significant Body Weight and BMI Reductions in Drug Compliant Subjects in Phase Ib Clinical Study | www.medicalnewstoday.com
1. DOV 21,947 in a phase Ib study produced a statistically significant reduction in plasma triglyceride levels, body weight, and Body Mass Index (BMI). 2. This compound is believed to not only manage depression but also impact weight gain. 3. A phase II study of DOV 21,947 is being delayed until the first quarter of 2008 to allow for sufficient capital to conduct the study and to further evaluate the protocol design. 4. Phase I studies of DOV 21,947 have shown that the compound was safe and well tolerated with a low incidence of adverse events.
Shire Takes Proactive Stance Regarding Daytrana Skin Patches
September 18, 2007
Shire withdraws some ADHD skin patches | www.reuters.com
1. Shire has withdrawn patches that had defective patch liners. 2. This defect is not related to safety or efficacy issues. 3. The cost to Shire is less than $10 million.
New Potentially Effective Antidepressants to be Marketed by a Potentially Effective Alliance
September 12, 2007
Lundbeck and Takeda form Alliance to Develop and Commercialize a Portfolio of Novel Compounds in the US and Japan for the Treatment of Mood and Anxiety Disorders | www.pipelinereview.com
1. Lu AA21004 and Lu AA24530 are two compounds with a great deal of potential and will be co-marketed jointly by Takeda and Lundbeck. 2. Lu AA21004 is the more advanced of the compounds and is currently in phase II development for the treatment of major depression. 3. The compounds potentially address some unmet needs as they have fast onset of effect and increased efficacy.
LY2140023: An Antipsychotic With A New Mechanism of Action
September 11, 2007
Investigational Agent Targeting Metabotropic Glutamate 2/3 Receptors Demonstrates Antipsychotic Activity in Humans, Study in Nature Medicine Finds | www.pipelinereview.com
1. LY2140023 is an antipsychotic agent that is a metabotropic glutamate 2/3 receptor agonist. This agent has a new mechanism of action that is efficacious in treating schizophrenia and potentially other neuropsychiatric conditions. 2. LY2140023 in addition to separating from placebo in a statistically significant manner demonstrated a safety and tolerability profile that lacked many of the problems of atypical antipsychotic agents. 3. This has great significance for Eli Lilly who manufactures Zyprexa. This compound despite having a great deal of efficacy in treating schizophrenia and bipolar disorders has been associated with metabolic side effects including hyperglycemia. (Lilly has recently settled Zyprexa class action suits.)
| Study Group Name | No. Members |
|---|---|
| Psychiatrists | 1535 |
| Psychiatrists (US) | 1136 |
| Economic Experts on Managed Care | 714 |
| Physicians who Treat ADHD (US) | 453 |
| Physicians who Treat Depression (US) | 448 |
Lawrence Ginsberg has not participated in any GLG Live Meetings.