Nasal spray launched to treat nocturia due to nocturnal polyuria
Avadel Pharmaceuticals plc has announced the launch of desmopressin acetate (NOCTIVA), an emulsified microdose nasal spray. Desmopressin is the first and only FDA-approved treatment proven to help adults with nocturia due to nocturnal polyuria, according to Avadel. The treatment’s formulation works in the kidneys to lessen nighttime urine production. The nasal spray is a proprietary emulsified microdose of desmopressin combined with a permeation enhancer that increases the transport of desmopressin across the nasal mucosa. Delivered via a unique spray pattern, NOCTIVA’s formulation substantially increases the bioavailability of the active drug, allowing for microdosing, rapid absorption, and consistency from dose to dose.
The RestoreX device is a next-generation form of traction therapy for the treatment of Peyronie’s disease. The device stretches and bends the penis to correct the curve and restore lost length. RestoreX also uses a patent-pending design that allows the user to counterbend in the direction opposite the Peyronie’s curvature. The counterbending provides site-specific therapeutic levels of traction to the plaque that has formed in the outer layers of the penis. The device, developed in cooperation with Mayo Clinic and manufactured and distributed by PathRight Medical, is FDA registered and is undergoing a clinical trial designed to assess preliminary efficacy on correcting the physical symptoms of Peyronie’s disease.
New data support use of MOSES holmium technology for stones, BPH
Lumenis Ltd. has announced the release of significant new clinical evidence in lithotripsy as well as initial clinical benefits in BPH treatments using the company’s MOSES technology. MOSES is a patent-protected technology for holmium laser treatments in both urinary stones and BPH. Recently presented data indicated that lithotripsy procedures conducted with the MOSES technology resulted in 20% reduction in procedure time, 25% reduction in fragmentation time, and 60% reduction in retropulsion. In addition, researchers presented initial experience with the MOSES technology that suggests advantages in prostate enucleation for BPH.
Ultrasound system features lightweight, ergonomic design
Siemens Healthineers has launched the ACUSON Juniper, a new ultrasound system with advanced applications and imaging performance while featuring a lightweight, ergonomic design and complete maneuverability for use across a wide variety of clinical segments. The system’s two standard USB ports enable quick transfer of images to patients, eliminating the need for printout documentation. The ACUSON Juniper is 40% quieter than other ultrasound systems in its class, according to Siemens Healthineers. Additionally, a protective sheet is available for the system’s key pad, to facilitate the reading and use of the controls while in a sterile environment such as the operating room. This protective skin can be disinfected for reuse.
Book provides comprehensive overview of urologic catheters
“Clinical Application of Urologic Catheters, Devices and Products” is designed to provide a comprehensive and state-of-the-art overview of the use of urologic catheters and devices in clinical practice, according to publisher Springer. Sections of the book have been structured to review the overall indication for the use of urologic catheters and devices, types available, complications, and management. Written entirely by urologic specialists, the book also includes highly practical presentations and of typical patients with catheters or devices seen in the clinical practice of geriatric urology, all in the form of case presentations with expert analysis and editorial commentary.
BLC agent’s indication extended to include flexible cystoscopes
Photocure ASA says the FDA approved its supplemental new drug application to extend the indication for Blue Light Cystoscopy (BLC) with Cysview to include flexible cystoscopes. This is the only combination of drug and device approved for the detection of bladder cancer, according to the company. The expanded indication includes the combination of Cysview with the KARL STORZ PDD Flexible Blue Light Videoscope System. The approval also expands the indication in the current rigid setting (transurethral resection of bladder tumor) by including the detection of carcinoma in situ in bladder cancer patients as well as the repeated use of BLC with Cysview.
Liquid biopsy test detects AR-V7 in men with advanced prostate Ca
Genomic Health, Inc. has launched the Oncotype DX AR-V7 Nucleus Detect test in the United States. The liquid biopsy test was developed by Epic Sciences to help prolong the lives of men with metastatic castration-resistant prostate cancer by accurately detecting a splice variant of the androgen receptor protein (AR-V7) in the nucleus of circulating tumor cells. Knowledge of a patient's AR-V7 status enables physicians to confidently decide whether men treated with an androgen receptor-signaling inhibitor (ARSI) therapy, such as enzalutamide (XTANDI) and abiraterone (ZYTIGA), need to start another type of ARSI or switch to chemotherapy, according to Genomic Health.
FDA supplemental NDA approved for OAB combination therapy
The FDA has approved a supplemental New Drug Application (sNDA) for the use of mirabegron in combination with the muscarinic antagonist solifenacin succinate for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. In the United States, mirabegron and solifenacin are marketed as Myrbetriq and VESIcare, respectively. Each is approved by the FDA as a monotherapy for OAB. The sNDA submission was based on data from three global phase III studies that evaluated combination therapy with mirabegron and solifenacin compared with each drug as monotherapy or placebo, according to Astellas.
PCa management simulator can help providers in treating patients
The National Comprehensive Cancer Network’s new Prostate Cancer Patient Management Simulator delivers virtual experiences that can help providers treat patients with cancer. The free simulator allows users to recognize the various clinical presentations for the disease, develop appropriate treatment plans based on NCCN guidelines, and explore approved drug indications and emerging therapies to integrate into treatment approaches. The simulation, which was created through a collaboration between NCCN and Syandus, allows users to test their knowledge by walking through the steps of treating virtual patients. The tool then provides feedback based on clinical choices and provides an opportunity to revise treatment approaches to successfully complete scenarios.
FDA approves new indication for bladder cancer imaging agent
Photocure ASA announced the launch of blue light cystoscopy with hexaminolevulinate hydro-chloride (HAL [Cysview]) for a new indication of surveillance cystoscopy of bladder cancer. The new FDA-approved indication was a result of a large phase III study using blue light rigid and flexible cystoscopes from KARL STORZ Endoscopy of America Inc., which showed that BLC with HAL significantly improves detection of patients with recurrent bladder cancer. HAL is an optical imaging agent used in the diagnosis and management of nonmuscle-invasive bladder cancer (NMIBC). In related news, KARL STORZ Endoscopy-America announced the commercial launch of the PDD Blue Light Flexible Video Cystoscopy System for enhanced detection of NMIBC.