PHARMACY

FDA approves Addyi, Sprout’s ‘female Viagra’

BY David Salazar

SILVER SPRING, Md. — The Food and Drug Administration handed down its anticipated approval of Sprout Pharmaceuticals’ Addyi (filbanserin 100 mg), a treatment for women with generalized hypoactive sexual desire disorder. The approval is the first for any drug addressing  sexual desire disorders, and the first HSDD, the most common form of female sexual dysfunction. 
 
“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction.”
 
 
HSDD is characterized by persistent lack of sexual thoughts and responsiveness, as well as an unwillingness to engage in sexual activity that causes distress and can’t be explained by other conditions or substances
 
Addyi was approved with a Rish Evaluation and Mitigation Strategy (REMS) program, which will require certification for both pharmacists and providers. The drug is expected to hit the market on Oct. 17. 
 
“It has been a remarkable journey to get to this breakthrough moment. Today we celebrate what this approval means for all women who have long awaited a medical treatment option for this life impacting condition,” Sprout CEO Cindy Whitehead said. “We applaud the FDA for putting the patient voice at the center of the conversation and for focusing on scientific evidence.”
 
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TruMedicines launches Kickstarter for Rx adherence app

BY DSN STAFF

SEATTLE — Big data and pharmaceutical tracking and authentication company TruMedicines on Tuesday launched a 40-day Kickstarter campaign for a smartphone app that promotes medication safety.

TruMedicines said the app will help stymy issues responsible for over a million deaths every year and billions of dollars in additional healthcare costs — counterfeit medication and adherence. Particularly with regard to counterfeit medication, TruMedicine’s David Prokop learned that people’s inability to figure out whether a drug is legitimate or not was a problem that needed fixing.

“When I learned about the epidemic of children dying due to counterfeit malaria pills, it became my mission to find a solution,” Prokop said.

The app requires a two-step authentication process — users first scan a QR code on the back of a TruMedicines box, and then take a photo of the pill, comparing it against the companies cloud database of medication. The process verifies where the drug was made, its expiration date and side effects. Designed to be accessible to people who are illiterate or have poor vision, the app provides information verbally and in large font in 52 languages.

Besides the issue of counterfeit medication is ensuring that patients take their medication properly and regularly — something that 90% of diabetes patients and 50% of cancer patients don’t fully do. So the TruMedicines app will send text message notifications to a patient’s family and doctor if a dose is skipped and will incentivize adherence through a rewards program.

“I’m thrilled that TruMedicines not only has the capability to dramatically reduce these avoidable deaths, but it also assists patients with compliance to ensure that medications are taken as prescribed,” Prokop said.

The Kickstarter campaign seeks to secure $150,000 to fund a April 2016 launch.  

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Aurobindo gets OK from FDA for Zyrtec generic

BY David Salazar

DAYTON, N.J. — Aurobindo Pharma Limited announced Tuesday that it had received approval from the Food and Drug Administration for its over-the-counter cetirizine hydrochloride in 5- and 10-mg dosage strengths. The drug is a generic version of Zyrtec.

The cetirizine hydrochloride tablets are indicated for temporarily relieves runny nose, sneezing, itchy, watery eyes and itching of the nose or throat caused by hay fever or other upper respiratory allergies.    

The product has an estimated market size of $264MM for the twelve months ending January 2014, according to IRI.

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