New Products: FDA approves oral agent for HSDD, app helps men with erectile dysfunction and more

FDA approves oral agent for women with hypoactive sexual desire

Raleigh, NC-Sprout Pharmaceuticals, Inc. has been granted FDA approval of flibanserin (Addyi), a once-daily, non-hormonal pill for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Filbanserin is the first and only FDA-approved treatment for this condition. Its approval is largely based on three North American phase III, 24-week, randomized double-blind, placebo-controlled, studies of premenopausal women with HSDD. In this population, filbanserin has demonstrated improvements in desire for sex, reducing distress from the loss of sexual desire, and increasing the number of satisfying sexual events, according to Sprout Pharmaceuticals The drug is expected to be available by Oct. 17, 2015. 

For more information, visit www.addyi.com.

New urology devices facilitate stone treatment, device passage

Center Valley, PA-Olympus has launched several new devices for stone treatment and other urologic applications. ShockPulse-SE (shown) is a next-generation CyberWand dual-action lithotripsy system with integrated suction and hand activation designed to fragment and remove stones more efficiently. The UltraTrack Hybrid Guidewire combines the flexibility of a hydrophilic wire at the tip and a stiff body to maintain position and assist in device passage. In the UroPass Access Sheath full portfolio, the hydrophilic-coated sheath and gradual tapered dilator tip eases placement and allows for multiple passage of endoscopes and retrieval devices. The sheath provides fast access through the urethra and to the kidney, enabling multiple passages of instruments safely, Olympus says. The 200 Series Laser Fiber balances a small diameter with optimal laser energy transmission, allowing scope flexibility and improved irrigation. In addition, Olympus now offers the urology market its Olympus Advantage Program, which is designed to reduce the overall cost of capital products such as rigid and flexible scopes, cameras, and processors. Customers who choose stone disposable devices will receive credits toward their Olympus capital equipment costs while reducing the overall spend.

For more information, visitwww.medical.olympusamerica.com.

Distribution of compounded urologic drugs expands to Texas, Virginia

San Diego-Imprimis Pharmaceuticals, Inc. has expanded the availability of its proprietary urologic compounded formulations to physicians and patients in Texas. The expansion resulted from Imprimis’ recent acquisition of a compounding pharmacy located outside of Dallas. Imprimis’ two existing compounding pharmacies also received licenses to dispense in Taxes and Virginia. The company’s urology formulations include Hep-Lido-A (alkalinized lidocaine and heparin) for interstitial cystitis and Tri-Mix (phentolamine, papaverine, and prostaglandin) for erectile dysfunction.

For more information, visit www.imprimispharma.com.

Online service helps patients choose surgeons, surgery packages

Aventura, FL-Surgeo is an online tool and service of health care logistics company Allevion, Inc. that helps consumers simplify the process of searching for and choosing a surgery package that best serves their needs. It allows comparisons of packages by surgeon, price, and location. Allevion says Surgeo positions surgeons in an exclusive network of providers, increases visibility to patients who need their services, gets patients to their office with files prepared as needed, and helps new patients who qualify to obtain financing if they need it. Current procedures include robotic prostatectomy, penile implant, male urethral sling placement, and male urinary sphincter placement.

For more information, visit www.surgeo.com.

App helps men determine presence of erectile dysfunction

Bangalore, India-ManipalAnkur has unveiled “Dr. Vasan’s CurED” app, which calculates the presence/absence and intensity of erectile dysfunction with advanced calculators. The app provides patients with convenient questions that determine whether they have ED and to what extent. Features include International Index of Erectile Function and Sexual Health Inventory for Men calculation for detecting treatment-related changes, and depending on the results, the ability to contact a doctor.

For more information, visit www.manipalankur.com.

Boston Scientific completes deal for AMS men’s, prostate health lines

Marlborough, MA-Boston Scientific Corp. has closed on the previously announced agreement with Endo International plc to purchase American Medical Systems’ Men’s Health and Prostate Health businesses, for $1.6 billion in up-front cash and a potential additional $50 million milestone based on 2016 sales. Boston Scientific said the acquisition positions Boston Scientific as a leader in urology, providing physicians and health care systems a comprehensive portfolio of proven technologies.

For more information, visit www.bostonscientific.com.

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