Regulators OK injectable med to bolster women's sex drive

24 Juin, 2019, 06:23 | Auteur: Yves Courtet
  • AMAG's auto-injector Vyleesi just won FDA nod to rival Sprout's Addyi in premenopausal women with hypoactive sexual desire disorder

Food and Drug Administration on Friday gave its approval to Vyleesi, a drug to treat women with low sexual desire.

The drug is injected under the skin of the abdomen or thigh at least 45 minutes prior to a sexual encounter, although the best timeframe for dosing could vary from user to user.

Friday's decision for Waltham, Massachusetts-based drugmaker Amag Pharmaceuticals marks only the second time regulators have approved a drug for the condition. "These women have suffered significantly, pretty much in silence, for a stigmatised condition, and many of them have not known that it's a treatable medical condition". It will be used to treat premenopausal women with a hypoactive sexual desire disorder, which is defined by a persistent lack of interest in sex, causing stress. Medications for men experiencing erectile dysfunction arrived on the market two decades ago.

But these treatments for women have provoked controversy.

Bremelanotide is not the first drug to be approved for this goal. But some opponents argued its risks outweighed its benefits. Vyleesi, which does not restrict alcohol use, is seen as having several advantages over Addyi, including tolerable side effects, rapid-acting nature and not having to take it every day, according to analysts. About 40% of patients in the clinical trials experienced nausea, most commonly with the first Vyleesi injection, and 13% needed medications for the treatment of nausea.

Vyleesi is the second treatment for HSDD cleared for marketing in the USA, following the pill Addyi, which was approved in 2015.

"Female sexual dysfunction is more complicated in some ways than male sexual dysfunction, so it's more hard to treat", Dr. Nicole Cirino, co-director of the Menopause and Sexual Therapy Clinic at Oregon Health and Science University's Center for Women's Health, told CNN. It is developed by Palatin Technologies, which granted exclusive licensing rights to Amag Pharmaceuticals.

One Dead, 10 Injured in South Bend Pub Shooting
He also acknowledged the department has fallen short in recruiting minority police officers and introducing body cameras. He arrived in SC to campaign on Saturday but he announced he would return for a town hall in South Bend on Sunday.

Grande distribution : Carrefour vend 80 % de ses activités en Chine
La transaction devrait être bouclée à la fin de l'année, sous réserve du feu vert des autorités chinoises de la concurrence. "Le prix pour l'acquisition de 80% des titres de Carrefour Chine est de 4,8 milliards de RMB, soit 620 millions d'euros .

Les NTIC : avantages et inconvénients
En effet, avoir mille et une tâches à accomplir à la fois, ça peut avoir des effets négatifs. En effet, les travailleurs effectuent les tâches beaucoup plus rapidement tout en conservant leur qualité de vie.

Vyleesi, like Addyi, probably won't be overprescribed, Cirino added. Addyi, made by Sprout Pharmaceuticals, never took off commercially, in large part because of a black-box safety warning that prohibited women from drinking alcohol before taking it.

Vyleesi's demonstrated increases in reported desire, measured on a five-point scale, are small.

WASHINGTON-U.S. women will soon have another drug option created to boost low sex drive: a shot they can give themselves in the thigh or abdomen that raises sexual interest for several hours.

That's because, she said, women with low sex drive continue to have sex with their partners, they just don't enjoy it. "The problem is, they're distressed about having that sex that they are having".

Some drug-industry critics questioned whether Vyleesi was the latest example of a company promoting a pharmaceutical solution for something that is, in reality, far more complex.

"I think it's worth noting what's an acceptable level of libido is socially influenced", said Dr Adriane Fugh-Berman, a professor in the department of pharmacology and physiology at Georgetown University Medical Center who studies pharmaceutical marketing.

Conseillé:

  • Cardi B Performs With Offset at BET Awards

    They join previously announced performers, Lil Nas X and Billy Ray Cyrus , Cardi B , DJ Khaled and Migos, just to name a few. Blige will receive the Lifetime Achievement Award and media mogul Tyler Perry will earn the Ultimate Icon Award.
    Félix Auger-Aliassime éliminé par Feliciano Lopez au Queen's

    Félix Auger-Aliassime éliminé par Feliciano Lopez au Queen's

    Gilles Simon s'est qualifié pour la finale du Queen's , samedi, après sa victoire contre Daniil Medvedev (6-7 [4], 6-4, 6-3). Nos standards:Les principes de Thomson Reuters Trust.
    US asks Pakistan to free blasphemy accused

    US asks Pakistan to free blasphemy accused

    The State Department had downgraded Pakistan's ranking to that of a CPC, a country of particular concern past year but waived the sanctions that it entailed.
  • Mauritanie : Ould Ghazouani se proclame président

    Mauritanie : Ould Ghazouani se proclame président

    Mais elle appelle à lever les obstacles au secteur privé, citant en premier lieu les difficultés d'"accès au crédit" et "la corruption".
    Pride parade culmination of month-long festivities in Toronto

    Pride parade culmination of month-long festivities in Toronto

    Thousands took to the streets for the city's annual Dyke March along Church St.in downtown Toronto on Saturday, June 22, 2019. Serial killer Bruce McArthur pleaded guilty earlier this year to murdering eight men with ties to the gay village.
    Massive crowd in Prague call for Czech PM’s resignation

    Massive crowd in Prague call for Czech PM’s resignation

    A day after police advised that the state prosecutor file charges against him, the minister of justice was changed. The two parties previously derailed an attempt to unseat the prime minister in November.
  • Unheralded Sucher seizes Travelers Championship lead

    Unheralded Sucher seizes Travelers Championship lead

    Sucher, who said he grew up in south Alabama doing "swamp stuff" like wrestling alligators and also played high school basketball. Australia's Jason Day (63) and England's Paul Casey (68) are among seven players tied for sixth at 7 under.
    Belmadi impose le black-out — Algérie-Kenya

    Belmadi impose le black-out — Algérie-Kenya

    Le match entre l'Algérie et le Kenya débutera juste après celui du Sénégal contre la Tanzanie, à 20:00 GMT. Parmi les favoris de cette CAN 2019 , l'Algérie n'a pas tremblé pour son entrée dans la compétition.
    EPL: Frank Lampard set to snub Chelsea

    EPL: Frank Lampard set to snub Chelsea

    Juve are said to be close to signing Ajax centre-back Mattijs de Ligt for £62m and already boast the talent of Cristiano Ronaldo. However, Derby are determined to keep hold of a manager who led them to the Championship play-off final in 2018/19.
  • Kawhi Leonard opts out, though Raptors are still alive

    Kawhi Leonard opts out, though Raptors are still alive

    Either one would (understandably) leave Raptors fans ecstatic that Masai Ujiri's bold trade paid off to an enormous degree. The Boston Celtics will likely fall off to a degree, but they should still be able to put together a competitive team.
    Porsha Williams & Dennis McKinley Call It Quits

    Porsha Williams & Dennis McKinley Call It Quits

    Weeks ago, fans of " Real Housewives of Atlanta " began to speculate Porsha Williams and Dennis McKinley had broken up. Porsha had announced before that they were expecting their first child together.

    Torres pays tribute to ‘best player’ Gerrard in retirement announcement

    Torres also remains open to the idea of another emotional return to Atletico in the future, after earning his coaching badges. I don't have the experience, the knowledge of managing, I need time to prepare myself for the biggest challenge'.


Populaire

Ricciardo given two time penalties
Ricciardo also received a total of three penalty points for the incidents, bringing his total up to five for the 12-month period. He also stated that the rumble strips in the turn made the vehicle more hard to control.

Sudan's transitional council deputy thanks Saudi Arabia, UAE for assistance
A file photo of Iranian-allied Yemeni rebel fighters. "We're prepared to negotiate with no preconditions". At the same time, Pompeo reiterated that the USA was prepared to negotiate with Iran to ease tensions.

British couple who sent money to son in IS territories spared jail
Police followed up with a second warning, telling Lane that "sending money to Jack is the same as sending money to Isis ". Now 23, Jack Letts has spent the last two years in a prison in Kurdish-held Rojava, northern Syria.

Vazquez's homer in 10th caps Red Sox rally past Blue Jays
But he walked the next batter, putting runners on first and second, then Jackie Bradley Jr. doubled off the Green Monster. In seven games against the Red Sox this season, he's batting.423 (11 for 26) with five homers and nine RBIs.

Lopez beats Simon to Queen's title in thriller
Simon, who has 14 titles but none on grass, took defeat in good heart. "I didn't have high expectations at all", he said. He was looking to become the first Frenchman to win this event in the Open Era.

Donald Trump accusé de viol par une éditorialiste américaine : les révélation choquantes
Donald Trump qui vient de fêter ses 73 ans fait, depuis quelques heures, l'objet de graves accusations. Le président américain dément formellement.

China-led trade pact RCEP gets support from Southeast Asian leaders
The Regional Comprehensive Economic Partnership (RCEP) includes all 10 ASEAN economies, plus India, Japan, South Korea, Australia and New Zealand.

Pakistan players hurt my media attack after India defeat, says Mohammad Hafeez
Sarfraz Ahmed-led side have won only one match out of five in the tournament and now in ninth place on the points table . However, he managed just 9 runs and gave away 11 in the only over he bowled in the crunch match against the Indian team.

Réunion cruciale du groupe GAFI aujourd'hui — Liste noire
En l'espace de 17 mois, la Tunisie a réussi à améliorer 29 recommandations et les hisser au niveau "élevé " ou "modéré " et au niveau "conforme ".

Comment devenir webmaster?
Il est amené à rajouter des textes, des images, des vidéos. Il procède également à l’analyse du trafic.