Sexual Issues A Major Concern For Cancer Patients Taking New Targeted Drugs

Main Category: Cancer / Oncology
Also Included In: Sexual Health / STDs;  Erectile Dysfunction / Premature Ejaculation
Article Date: 13 Oct 2010 – 0:00 PDT

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New drugs that target specific molecular mechanisms of cancer have improved the treatment of cancer patients in recent years, but those benefits may come with a cost to the patient’s sex life, researchers have found.

At the 35th Congress of the European Society for Medical Oncology (ESMO) in Milan, Italy, French researchers reported on one of the few studies to investigate the impact of cancer therapy on the sexual functioning of patients.

Dr Yohann Loriot and Dr Thomas Bessede from Institut Gustave Roussy in Villejuif, France and colleagues found that patients taking targeted therapies had significantly decreased levels of sexual function and satisfaction.

“The new molecular targeted therapies have been available for 6 or 7 years and researchers and physicians have observed some new side-effects not often reported with chemotherapy such as cutaneous side-effects and gastro-intestinal toxicity. But very few studies have been conducted in the field of sexuality, mainly because patients are not willing to talk with their physicians on this topic,” Dr Loriot said.

The researchers surveyed 51 patients (40 men and 11 women) who had been taking molecular targeted therapies for more than three months without progressive disease about changes in their sexual life.

The drugs involved were sunitinib, sorafenib, temsirolimus, everolimus, bevacizumab, tarceva and cetuximab. Men completed the International Index of Erectile Function (IEEF) questionnaire –which includes questions on erectile function, intercourse satisfaction, orgasmic function, sexual desire and overall satisfaction.

Women in the study completed the Female Sexual Function Index (FSFI) questionnaire, which includes questions on desire, arousal, lubrication, orgasm, satisfaction and pain.

The median overall IIEF score for men was 40, just 53% of the maximum score. For women, the median FSFI score was 8.4, just 24% of the maximum.

“The sex lives of the patients in our study had reduced quality and intensity,” Dr Loriot said. “We also found that more than half of the patients expressed a wish for a satisfying sexuality, but many of them found it difficult to initiate a discussion on the topic with their doctors.”

The impact of treatment on the sexuality of cancer patients is poorly understood, and is generally not considered in clinical trials of treatments, Dr Loriot said.

“Oncologists can address this issue first by assessing this concern more often in clinical trials, and by talking with their patients about it,” he said.

He suggested that oncologists could offer patients an assessment for sexual disorders during their treatment course, establish an outpatient clinic to deal with sexual disorders, or, if needed, refer patients to a specialist.

Sexuality is a major concern for cancer patients, as it is for everyone, noted Professor Raphael Catane, Chair of the department of oncology at Sheba Medical Center in Tel Hashomer, Israel. “The disease itself, and frequently its therapy, may have a major detrimental effect on the patient’s sex life. It is hoped that the new biological/targeted treatments would be less injurious to the sexual life of cancer patients. ”

“The study by this French group has taken an important step toward understanding the effect of biological/targeted treatments on sexuality,” Prof Catane said. “They meticulously reviewed the sexual function of their patients receiving biological agents. The results show a diminished sexual drive and pleasure, but the degree and the duration, and how it compares to the standard/conventional therapy, is not yet known. This study can be a basis for further investigation of this very important aspect of cancer therapy.”

Source:
Vanessa Pavinato

European Society for Medical Oncology





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NovaDel Pharma Inc. Announces Positive Data From Pilot Pharmacokinetic Study Comparing Duromist™ (Sildenafil Citrate Oral Spray) To Viagra(R)

 

Main Category: Erectile Dysfunction / Premature Ejaculation
Article Date: 20 Oct 2010 – 1:00 PDT

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NovaDel Pharma Inc. (OTCBB: NVDL), a specialty pharmaceutical company developing oral spray formulations for a broad range of marketed pharmaceutical products, announced pharmacokinetic (PK) and safety results from its pilot PK study comparing Duromist™ to Viagra®. Duromist™ is NovaDel’s oral spray formulation of sildenafil citrate. Viagra® is the tablet formulation of sildenafil citrate developed and marketed by Pfizer. Sildenafil citrate is a leading drug indicated for the management of pulmonary hypertension and erectile dysfunction. NovaDel now plans to review the results from this study with the FDA to obtain guidance on defining definitive clinical trial requirements as a pathway to NDA approval.

Objectives of the Study

This pilot PK study was designed primarily to assess the relative bioavailability of one, two and three doses of 10 mg/0.12ml of Duromist™, compared to that of the 25 mg Viagra® tablet in healthy adult male subjects.

The secondary objective was to assess the relative safety of Duromist™ following single oral dose administration compared to that of 25 mg Viagra® tablets. Safety assessments included evaluation of changes in orthostatic hypotension, oral irritation, vital sign and electrocardiogram assessments.

Results of the Study

The preliminary study data demonstrated that 20 mg or two sprays of Duromist™ is bioequivalent to the 25 mg Viagra® tablet with respect to systemic exposure (AUC0-inf). The mean AUC0-inf for the 10 mg or one spray dose was approximately 40% of the 25 mg Viagra® tablet, as expected. The mean AUC0-inf for the 30 mg (or three spray) dose was approximately 40 % higher than the 25 mg Viagra® tablet which is about 20% higher than expected. The increased systemic exposure (AUC) observed with the 20 and 30 mg oral spray doses compared to the Viagra® tablet is suggestive of absorption of sildenafil via the oral transmucosal route.

A slightly lower Cmax than that of the 25 mg Viagra® tablet was observed with the 20 mg oral spray dose. The Tmax for the 20 mg oral spray dose was essentially the same as the 25 mg Viagra® tablet (1.10 and 1.04 hour, respectively).

N-desmethylsildenafil is an active metabolite of sildenafil formed as a result of first-pass liver metabolism. TheDownload the best Android apps and games on Aptoide apk  Discover, download and share Android APK rate of metabolite formation with the oral spray is different than that observed with the reference tablet and is consistent with transmucosal absorption.


Duromist™ demonstrated an excellent safety profile and was well tolerated in this pilot PK study. There was no evidence of oral irritation and no adverse events were reported after administration of up to three doses of Duromist™. Vital signs were within normal range and there were no episodes of orthostatic hypotension observed in any of the four treatment periods. No changes were observed in the subjects’ electrocardiograms in any of the four treatment periods.

“These results are encouraging and demonstrate that greater bioavailability can be achieved with sildenafil administered as an oral spray form with the potential for a differentiated, patented Duromist™ product,” commented Mr. Steven B. Ratoff, NovaDel’s Chairman of the Board, President Chief Executive Officer. “This initial clinical study provides NovaDel with a solid foundation for our future clinical development efforts.”

About the Study

This was a single-center, open-label, single-dose, randomized, four-period, four-treatment crossover study under fasting conditions. The total number of healthy adult male subjects enrolled in the study was 24. All subjects were required to stay at the clinical site for at least 24 hours after each treatment period.

The Duromist™ oral spray test article used in this study was supplied as 10 mg/120 µl sildenafil per spray actuation. The 25 mg sildenafil citrate tablet was supplied from commercial sources as Viagra® from Pfizer Inc.

Measurements:

Pharmacokinetic: The following parameters were used in the data analysis for plasma sildenafil and N-desmethylsildenafil concentrations: AUC0-t, The area under the plasma concentration versus time curve, from time 0 to the last measurable concentration; AUC0-inf, Calculated as the sum of the AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant; AUC0-t/AUC0-inf, The ration of the AUC0-t to AUC0-inf; Cmax, The maximum measured plasma concentration observed; Tmax, defined as the time point of Cmax; Kel, The apparent first-order terminal elimination rate constant; T1/2, The apparent first-order terminal elimination half-life; Ratio Metabolite/Parent, The ratio of the metabolite/parent assessed at each concentration, Cmax, AUC0-t, AUC0-inf.

Safety: Vital signs (supine and standing); Electrocardiogram at screening and post-dose; Changes in physical examinations, including oral soft tissue examinations at and after each oral spray dosing, laboratory parameters and adverse events.

About Erectile Dysfunction

Erectile dysfunction (ED) is a condition in which men are unable to achieve penile erection or are unable to sustain an erection sufficient for successful sexual intercourse. In the United States alone, it is estimated that 18 million individuals suffer from ED with the disorder being most prevalent in men age 40 years and above. Since the risk of developing ED increases with age, the increasingly aged population and other risk factors such as physical inactivity, smoking and high cholesterol are expected to lead to an increase in the number of men with this condition over the next few years.

Source:

NovaDel Pharma Inc.

 





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Apricus Bio Announces First Patent Grant For Femprox(R) In Japan

Main Category: Erectile Dysfunction / Premature Ejaculation
Article Date: 20 Oct 2010 – 2:00 PDT

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Apricus Biosciences, Inc., (“Apricus Bio”) (Nasdaq: APRI) backed by a revenue generating CRO business and seeking to leverage its multi-route NexACT® drug delivery technology and internal pipeline through out-licensing partnerships, today announced that the Japanese Patent Office has issued a Decision to Grant a Patent for the Company’s application on Femprox entitled, “Compositions and Methods for Amelioration of Human Female Sexual Dysfunction.” This patent, when issued, will provide Japanese patent protection to December 2019, and is one in a series of patents and pending applications that Apricus Bio owns on Femprox and the underlying NexACT technology.

“Compositions and Methods for Amelioration of Human Female Sexual Dysfunction.”

Commenting on today’s news, Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio, stated, “We are very pleased with our first patent allowance for Femprox in Japan. We continue to aggressively pursue intellectual property (“IP”) coverage for our technology and product candidates under development and this allowance adds to the strength of our overall IP position. In addition to the newly allowed claims in Japan, we have corresponding coverage and protection for Femprox in many other major international markets. The advancement of our patent portfolio comes at an optimal time, as we are in active discussions with potential partners to out-license Femprox.”

Femprox is an alprostadil-based cream intended for the treatment of female sexual arousal disorder. Apricus has completed nine clinical studies to date, including one, 98-patient Phase 2 study in the U.S. and a 400-patient proof-of-concept Phase 2/3 study in China, where the cost for conducting clinical studies was significantly lower than in the U.S.

Source:

Apricus Biosciences




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