FDA told more study on testosterone treatments needed; AbbVie's AndroGel a leading product in that niche
An expert panel recommended that the Food and Drug Administration tighten restrictions on the use of testosterone drugs, a move that could put a dent in sales of one of AbbVie’s billion-dollar drugs.
Bloomberg explained that North Chicago-based AbbVie (NYSE: ABBV) pulled in about $1.04 billion in sales of its testosterone therapy AndroGel last year. But the panel of FDA advisers voted 20-1 in favor of new trials to learn more about heart risks from various testosterone drugs, the report said,… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - September 18, 2014 Category: Pharmaceuticals Source Type: research
Federal Trade Commission sues AbbVie, Teva in "pay for delay" deal
The Federal Trade Commission filed a complaint Monday against AbbVie and Teva Pharmaceutical Industries alleging the companies illegally blocked American consumers’ access to lower-cost versions of the testosterone replacement therapy AndroGel.
According to the FTC complaint, AbbVie (NYSE: ABBV) of Chicago and its partner Besins Healthcare Inc. allegedly filed baseless patent infringement lawsuits against potential generic competitors to delay the introduction of lower-priced versions of AndroGel,… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - September 9, 2014 Category: Pharmaceuticals Authors: John George Source Type: research
Factors Influencing Prostate‐Specific Antigen Response among Men Treated with Testosterone Therapy for 6 Months
ConclusionsOverall, T‐gel treatment was associated with a minor increase in PSA, of questionable clinical significance. Factors predicting greater PSA increases included age ≥60 years, baseline T ≤250 ng/dL, and %fPSA <20%. Men with T >250 ng/dL and age <60 years demonstrated minimal or no PSA change. Morgentaler A, Benesh JA, Denes BS, Kan‐Dobrosky N, Harb D, and Miller MG. Factors influencing prostate‐specific antigen response among men treated with testosterone therapy for 6 months. J Sex Med **;**:**–**. (Source: The Journal of Sexual Medicine)
Source: The Journal of Sexual Medicine - August 18, 2014 Category: Sexual Medicine Authors: Abraham Morgentaler, Janet A. Benesh, Bela S. Denes, Natalia Kan‐Dobrosky, Diala Harb, Michael G. Miller Tags: Original Research Source Type: research
Mylan gets 100 brands, big sales force outside U.S. in deal with Abbott
What will Mylan Inc. get out of its acquisition of the non-U.S. generic pharmaceutical division of Abbott?
The deal includes more than 100 brands that are sold in developed countries including Japan, Canada, Australia, New Zealand, Italy, the United Kingdom and Germany, with about $1.9 billion in annual sales. That includes both branded generic and nonbranded Abbott products including Creon, Influvac, Brufen and Androgel. Some are patent protected or have other additional growth opportunities.
That… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - July 14, 2014 Category: Hospital Management Authors: Paul J. Gough Source Type: research
Pharmacokinetics and bioavailability of a new testosterone gel formulation in comparison to Testogel® in healthy men
In conclusion, the new testosterone formulation showed higher bioavailability, and the ability to deliver more testosterone in a smaller volume. (Source: Clinical Pharmacology in Drug Development)
Source: Clinical Pharmacology in Drug Development - May 8, 2014 Category: Drugs & Pharmacology Authors: Håkan Olsson, Rikard Sandström, Anders Neijber, Dario Carrara, Lars Grundemar Tags: Article Source Type: research
Effect of testosterone on markers of mitochondrial oxidative phosphorylation and lipid metabolism in muscle of aging men with subnormal bioavailable testosterone.
CONCLUSION: The beneficial effect of testosterone treatment on lipid oxidation is not explained by increased abundance or phosphorylation-dependent activity of enzymes known to regulate mitochondrial biogenesis or markers of OxPhos and lipid metabolism in skeletal muscle of aging men with subnormal bioavailable testosterone levels.
PMID: 24760536 [PubMed - as supplied by publisher] (Source: European Journal of Endocrinology)
Source: European Journal of Endocrinology - April 23, 2014 Category: Endocrinology Authors: Petersson SJ, Christensen LL, Kristensen JM, Kruse R, Andersen M, Højlund K Tags: Eur J Endocrinol Source Type: research
Transdermal Testosterone Improves Verbal Learning and Memory in Postmenopausal Women Not on Estrogen therapy.
ConclusionsThe small but statistically significant effect of testosterone treatment on verbal learning and memory in postmenopausal women provides the basis for further clinical trials.This article is protected by copyright. All rights reserved. (Source: Clinical Endocrinology)
Source: Clinical Endocrinology - April 9, 2014 Category: Endocrinology Authors: Susan R Davis, Fiona Jane, Penelope J Robinson, Sonia L Davison, Roisin Worsley, Paul Maruff, Robin J Bell Tags: Original Article Source Type: research
Testosterone, anastrozole, factor V Leiden heterozygosity and osteonecrosis of the jaws
Our specific aim is to describe the development of thrombotic osteonecrosis of the jaws after testosterone–anastrozole therapy in a 55-year-old white man subsequently found to have previously undiagnosed factor V Leiden heterozygosity. Before the diagnosis of V Leiden heterozygosity, he was given testosterone gel, 50 mg/day, and on testosterone, serum testosterone (963 ng/dl) and estradiol were high (50 pg/ml). Anastrozole was started, and testosterone was continued. Six months later, osteonecrosis of the jaws was diagnosed. Exogenous testosterone is aromatized to estradiol and estradiol-induced thrombophilia, when...
Source: Blood Coagulation and Fibrinolysis - March 28, 2014 Category: Hematology Tags: Case Reports Source Type: research
FSH Suppression Does Not Affect Bone Turnover in Eugonadal Men.
Conclusion: When gonadal steroid levels are held constant, short-mid term suppression of FSH does not affect bone turnover in men. FSH does not appear to be a significant regulator of bone metabolism in eugonadal men.
PMID: 24646101 [PubMed - as supplied by publisher] (Source: The Journal of Clinical Endocrinology and Metabolism)
Source: The Journal of Clinical Endocrinology and Metabolism - March 19, 2014 Category: Endocrinology Authors: Uihlein AV, Finkelstein JS, Lee H, Leder BZ Tags: J Clin Endocrinol Metab Source Type: research
Acute and short term chronic testosterone fluctuations effects on glucose homeostasis, insulin sensitivity and adiponectin. A randomized, double-blind, placebo-controlled, cross-over study.
Conclusions: These data show that testosterone can act through putative fast nongenomic pathways to affect adiponectin levels in humans. The early hypogonadal state is characterized by a marked shift in fuel oxidation from lipids towards glucose, which partly may rely on buffering capabilities of adiponectin.
PMID: 24606070 [PubMed - as supplied by publisher] (Source: The Journal of Clinical Endocrinology and Metabolism)
Source: The Journal of Clinical Endocrinology and Metabolism - February 28, 2014 Category: Endocrinology Authors: Høst C, Gormsen LC, Hougaard DM, Christiansen JS, Pedersen SB, Gravholt CH Tags: J Clin Endocrinol Metab Source Type: research
A Multicenter, Open-Label, Observational Study of Testosterone Gel (1%) in the Treatment of Adolescent Boys With Klinefelter Syndrome or Anorchia
Conclusions: Once-daily testosterone gel application increased serum testosterone levels into the pubertal range and maintained pubertal testosterone levels during 6-month treatment. In this study, testosterone gel 1% raised testosterone levels and was associated with cough as the most common AE. (Source: Journal of Adolescent Health)
Source: Journal of Adolescent Health - September 16, 2013 Category: Child Development Authors: Alan D. Rogol, Ronald S. Swerdloff, Edward O. Reiter, Judith L. Ross, Troy L. ZumBrunnen, Gregg A. Pratt, John J. Brennan, Janet Benesh, Natalia Kan-Dobrosky, Michael G. Miller Tags: Original Articles Source Type: research
Prostate volume and growth during testosterone replacement therapy is related to visceral obesity in Klinefelter syndrome.
CONCLUSIONS: This study showed that visceral obesity, insulin-resistance, lipid and glucose metabolism alterations are associated with prostate volume and growth during T replacement therapy in KS, independently from androgen or estrogen levels. This latter findings might provide the basis for a better management and follow-up of KS subjects.
PMID: 24001894 [PubMed - as supplied by publisher] (Source: European Journal of Endocrinology)
Source: European Journal of Endocrinology - September 3, 2013 Category: Endocrinology Authors: Selice R, Caretta N, Di Mambro A, Torino M, Palego P, Ferlin A, Foresta C Tags: Eur J Endocrinol Source Type: research
Testosterone Deficiency is Associated with Increased Risk of Mortality and Testosterone Replacement Improves Survival in Men with Type 2 Diabetes.
Conclusions- Low testosterone levels predict an increase in all-cause mortality during long-term follow up. Testosterone replacement may improve survival in hypogonadal men with type 2 diabetes.
PMID: 23999642 [PubMed - as supplied by publisher] (Source: European Journal of Endocrinology)
Source: European Journal of Endocrinology - September 2, 2013 Category: Endocrinology Authors: Muraleedharan V, Marsh H, Kapoor D, Channer KS, Jones TH Tags: Eur J Endocrinol Source Type: research
Testosterone Restoration by Enclomiphene Citrate in Men with Secondary Hypogonadism: Pharmacodynamics and Pharmacokinetics
ConclusionsEnclomiphene citrate increased serum LH and TT; however, there was not a temporal association between the peak drug levels and the Cmax levels LH or TT.
Enclomiphene citrate consistently increased serum TT into the normal range and increased LH and FSH above the normal range. The effects on LH and TT persisted for at least one week after stopping treatment. (Source: BJU International)
Source: BJU International - July 12, 2013 Category: Urology & Nephrology Authors: Ronald Wiehle, Glenn R. Cunningham, Nelly Pitteloud, Jenny Wike, Kuang Hsu, Gregory K. Fontenot, Michele Rosner, Andrew Dwyer, Joseph Podolski Tags: Sexual Medicine Source Type: research
Oral Enclomiphene Citrate Stimulates the Endogenous Production of Testosterone and Sperm Counts in Men with Low Testosterone: Comparison with Testosterone Gel
ConclusionsEnclomiphene citrate increased testosterone and sperm counts. Concomitant changes in LH and FSH suggest normalization of endogenous testosterone production and restoration of sperm counts through the hypothalamic–pituitary–testicular axis. (Source: The Journal of Sexual Medicine)
Source: The Journal of Sexual Medicine - March 26, 2013 Category: Sexual Medicine Authors: Jed Kaminetsky, Michael Werner, Greg Fontenot, Ronald D. Wiehle Tags: Original Research Source Type: research
