Dutasteride application for PCa prevention withdrawn; will be resubmittedDecember 17th 2009
GlaxoSmithKline has announced that in order to provide an update to the application, the company is withdrawing its supplemental new drug application for dutasteride (Avodart) for prostate cancer risk reduction among men at increased risk of developing the disease.
Intravesical agent is effective option for BCG-refractory bladder cancerDecember 17th 2009
Intravesical valrubicin (Valstar) provides an effective and tolerable alternative to cystectomy for some heavily pretreated patients with carcinoma in situ that is refractory to bacillus Calmette-Guerin, according to a University of Chicago study.
Degarelix associated with lower risk of PSA recurrence, death vs. leuprolideDecember 17th 2009
Degarelix (Firmagon) is as effective as leuprolide (Lupron Depot) in reducing and sustaining castrate levels of testosterone, but during the first year of treatment, patients receiving degarelix have a significantly lower risk of PSA progression or death than those receiving leuprolide, according to a study presented at the Society of Urologic Oncology annual meeting in Bethesda, MD.
ACP guideline: Oral therapy improves erectile function in men with EDNovember 5th 2009
The American College of Physicians (ACP) has issued a new guideline that strongly recommends that physicians initiate therapy with an oral phosphodiesterase type-5 inhibitor in men who seek treatment for erectile dysfunction unless they have a contraindication to PDE-5 inhibitors, such as nitrate therapy.
Combination therapy offers benefits for men with BPHOctober 29th 2009
Final results from a large, 4-year study shows that combination treatment with dutasteride (Avodart) and tamsulosin (Flomax) reduces the risk of acute urinary retention or BPH-related surgery and reduces the risk of BPH clinical progression more than tamsulosin alone.
Oxybutynin gel does not impact cognition, study findsOctober 15th 2009
Oxybutynin chloride gel 10% (Gelnique) appears comparable to placebo in its effect on memory tests and other cognitive functions in older healthy adult subjects when compared with immediate-release oral oxybutynin treatments, according to research presented at the International Continence Society annual meeting in San Francisco.
Intravesical therapy available for aggressive bladder cancerSeptember 24th 2009
Endo Pharmaceuticals has announced the reintroduction of valrubicin (VALSTAR) intravesical therapy for the treatment of Bacillus Calmette-Guérin (BCG)-refractory carcinoma in situ (CIS) of the bladder for whom immediate removal of the bladder would be associated with unacceptable medical risks.
Estrogen receptor modulator reduces ADT fracturesSeptember 1st 2009
Androgen deprivation therapy leads to an increased risk of bone fractures and other side effects of estrogen deficiency in men with prostate cancer, but those effects can be successfully treated with the use of an oral selective estrogen receptor modulator, suggest the results of a large, prospective, randomized tria presented at the AUA annual meeting in Chicago.
Neoadjuvant chemo combo no 'silver bullet' in prostate cancerSeptember 1st 2009
In a phase II study, about 40% of men with clinically localized, high-risk prostate cancer were free of biochemical recurrence at 18 months when treated with neoadjuvant docetaxel (Taxotere) and ketoconazole followed by surgical excision, according to research presented at the AUA annual meeting.
Black box warnings added to botulinum toxin labels; names revisedAugust 27th 2009
The FDA has announced that boxed warnings are now included on labels of four botulinum toxin drug products, revising a previous safety alert on the products. The products also now include medication guides for patients, as mandated by FDA in April.
Phase III trial for premature ejaculation agent meets endpointsAugust 13th 2009
A second and final phase III, multicenter, double-blind, placebo-controlled study of PSD502 for premature ejaculation treatment has met all endpoints, according to Sciele Pharma and Plethora Solutions Holdings. Those endpoints include intra-vaginal ejaculation latency time and the index of premature ejaculation (IPE; ejaculatory control, sexual satisfaction, and distress domains).
Drug targeting BRCA gene mutations shows promise in prostate cancerJuly 16th 2009
Patients with inherited forms of advanced prostate, breast, and ovarian cancers caused by mutations in the BRCA1 and BRCA2 genes experienced tumor shrinkage without major side effects when treated with the investigational drug olaparib (AZD-2281), a recently published phase I study showed.
FDA requires label changes for testosterone gel safetyJuly 16th 2009
The FDA is requiring manufacturers of two prescription topical testosterone gel products, AndroGel 1% and Testim 1%, to include a boxed warning on the products? labels after receiving reports of adverse effects in children who were inadvertently exposed to testosterone through secondary exposure.