Friday April 26, 2019

Addyi: an antidepressant, not female Viagra

0
//

25FactsAboutFlibanserin  By NewsGram Staff Writer

While sexual problems remain a more clandestine affair for women than men, a respite in the name of Addyi has been introduced. This pink pill can pull out women from their depression which is caused due to their sexual inactivity.

With the US FDA giving a green signal to Flibanserin, commonly known as Addyi, the pharmaceutical industry has received its first drug which can treat a flagging or absent libido in women.

Addyi is erroneously being called as the “female Viagra”. However, that is not the case! While Viagra treats erectile dysfunction and focuses on the genitals of a man, Addyi works on the central nervous system, thereby targeting the brain and not the genitals.

Sprout Pharmaceuticals, the manufacturer of this pill won the FDA approval after two consecutive rejections in the year 2010 and 2013 respectively. The approval of Addyi is accompanied by various side-effects and caveat. Since Addyi targets the brain, it is classified under the category of antidepressants.

This drug comes with side-effects that include dizziness, nausea, fatigue and somnolence. While Viagra is a pill that men take before a sexual encounter, Addyi needs to be taken everyday. Moreover, this pill can be prescribed only by doctors and apothecaries who watch an online presentation and pass a test related to it.

lady-viagra

This prescription of this drug doesn’t entail that the woman is ill or is undergoing some relationship problems. Instead, this pill is dispensed for women whose loss of sexual desire causes marked distressed or depression in some cases.

While Dr Lauren Streicher, associate professor of clinical obstetrics and gynecology at Northwest University believes that this pill will induce women to talk about their sexual problems, Adriane Fugh-Berman, a pharmacology professor and director of PharmedOut thinks that such drugs open way for other “bad drugs” to enter into the market.

Next Story

FDA Approves Device to Treat Heart Failure Patients

The health body has granted approval of the Optimizer Smart system to US-based Impulse Dynamics

0
www.fdalawyersblog.com

The US Food and Drug Administration has given approval for a new device that would help treat patients with life-threatening heart failure, and address an unmet need in patients who fail to get adequate benefits from standard treatments and have no alternative treatment options.

The Optimizer Smart system is comprised of several components, including an implantable pulse generator, battery charger, programmer and software. The pulse generator is implanted under the skin in the upper left or right area of the chest and connected to three leads that are implanted in the heart.

After the device is implanted, a physician tests and programmes the device, which delivers electrical impulses to the heart during regular heartbeats to help improve the heart’s squeezing capability.

The device would be beneficial for patients not suited to treatment with other heart failure devices such as cardiac resynchronisation therapy to restore a normal timing pattern of the heartbeat, the US FDA noted in a statement.

“Patients with moderate-to-severe chronic heart failure have limited treatment options. And for those who are unable to be treated due to underlying conditions or who have not responded to available treatments, their quality of life may be impacted, with limits on the types of physical activities they can do,” said Bram Zuckerman, Director at FDA’s Centre for Devices and Radiological Health.

Photo Credit: www.medscape.com

“The FDA recognised the unmet need for these patients and worked with the manufacturer…to efficiently bring this product to market, while ensuring it meets our regulatory requirements for safety and effectiveness,” Zuckerman added.

For the study, the US FDA evaluated data from two clinical trials with a total of 389 patients with moderate-to-severe heart failure.

All patients received optimal medical therapy and 191 patients also received an Optimizer Smart system implant.

Also Read- Microsoft to Notify Users About End of Windows 7

The Optimizer Smart system improves quality of life and functional status of certain heart failure patients.

The health body has granted approval of the Optimizer Smart system to US-based Impulse Dynamics. (IANS)