Potential Alzheimer’s Drug Enters Phase I Trial
Kareus Therapeutics SA, a private biotechnology company, has announced the start of a Phase I clinical study following the Investigational New Drug approval from the U.S. Food and Drug Administration for the development of KU-046, a first-in-class, disease-modifying new chemical entity discovered for the treatment of Alzheimer’s disease using Kareus’ proprietary bioenergetics and KARLECT platforms.
The Phase I clinical trial is a randomized, double-blind, placebo-controlled two-part study to assess the safety, tolerability, and pharma-cokinetics of single ascending oral doses and of multiple ascending oral doses of KU-046 in 54 healthy young volunteers. The study is being conducted by biopharmaceutical service provider Quintiles in Kansas.
Kareus has developed a pipeline of novel molecules targeting diseases of the central nervous system based on its proprietary KARLECT chemistry and drug discovery platforms, which target dysfunctional energy production in neurons. KU-046 targets bioenergetics pathways upstream from the increased amyloid beta peptide production found in Alzheimer’s disease. It has demonstrated significant improvement in cognition in a number of pre-clinical models.
Source.“Kareus Therapeutics Announces Phase I Trial for Product in Alzheimer’s Disease.” (2013, January 3). Retrieved January 29, 2013, from the PR Newswire website: http://s.tt/1xUf5.
One Drug Approved, Another Studied for Overactive Bladder
The U.S. Food and Drug Administration (FDA) has approved Oxytrol for Women® (oxybutynin transdermal), the first over-the-counter treatment for overactive bladder (OAB) in women 18 and older. Oxytrol will remain available for men with OAB by prescription only.
Oxytrol for Women is a patch that is applied to the skin every 4 days. The patch delivers 3.9 mg of oxybutynin per day. Safety and effectiveness for over-the-counter use of the drug were established in more than 5,000 participants taking part in nine studies. Overall, results from these studies showed that consumers can understand the information on the label, properly select whether the product is right for them, and use the drug appropriately.
Meanwhile, TheraVida, Inc., a clinical-stage biopharmaceutical company, announced positive results from a Phase II clinical trial of Tolenix™ (THVD-201) for the treatment of OAB and urge urinary incontinence (UUI). Tolenix is a twice-daily proprietary combination of tolterodine, a muscarinic antagonist used to treat OAB, and pilocarpine, a muscarinic agonist approved to treat dry mouth.
The objectives of the randomized, double-blind, multiple-crossover Phase II trial were to assess the safety and efficacy of Tolenix in reducing the frequency of urination and incontinence episodes per day, as compared to both placebo control and active control Detrol® (tolterodine tartrate). In addition, common side effects of muscarinic antagonist therapies, such as dry mouth, were carefully assessed in the 138 patients enrolled in the trial. This international trial was conducted in South Korea, Australia, and New Zealand.
Patients receiving Tolenix (2 mg tolterodine plus 9 mg pilocarpine, administered twice daily) experienced statistically significant improvements in their OAB and UUI symptoms over placebo control, as well as efficacy similar in magnitude to the maximum dose of active control Detrol (2 mg tolterodine, administered twice daily). Patients receiving Tolenix exhibited no significant safety issues and demonstrated statistically significant and clinically meaningful improvements in their saliva production and dry mouth side effects, as compared to active control Detrol.
This Phase II study also demonstrated a favorable therapeutic index, which may enable higher dosing of Tolenix in some patients. A higher dose of Tolenix (3 mg tolterodine plus 13.5 mg pilocarpine, administered twice daily) was studied in a 12-week open-label extension period in a subset of patients in this Phase II trial. In this extension period, the higher dose of Tolenix exhibited the potential to provide greater bladder control while minimizing dry mouth side effects. TheraVida intends to conduct additional international clinical trials of Tolenix in patients with OAB and UUI.
Sources.“FDA Approves Over-the-Counter Oxytrol for Women to Treat Overactive Bladder.” (2013, January 25). Retrieved January 29, 2013, from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm336815.htm.“TheraVida Announces Positive Top-Line Phase 2 Results for Tolenix (THVD-201) in Patients with Overactive Bladder and Urge Urinary Incontinence.” (2013, January 3). Retrieved January 29, 2013, from the PR Newswire website: http://s.tt/1xUOo.
Pill Crusher Speeds Up Medication Passes
First Crush, a new automatic pill crusher that produces 200% more fine powder than the competition, is making medication passes faster and easier. Manufactured by First Wave Products Group, LLC, First Crush provides a cleaner, easier, and more effective method for mixing tablet medications into food and tubes.
Traditional manual drug crushers have one major flaw: The quality and fineness of the powder is directly affected by the physical strength and abilities of the user. Incomplete crushing leads to clogged feeding tubes; spit-outs; problems swallowing for the client; wasted, improper, or inconsistent dosage; residue to clean; and other issues during medication passes.
First Crush’s patented dual-action system automatically crushes and grinds the pill to the optimal fineness for better consistency and fewer dosing issues. In addition, the absence of hand-grinding means fewer potential work-related injuries to staff.
Complementing this innovative system is First Crush’s unique CompleteRX Cups. Made with a U.S. Food and Drug Administration-cleared anti-static coating to help reduce medication loss, CompleteRX Cups are placed in the unit so that the pills are crushed, mixed, and served all in the same container.
The First Crush pill crusher itself is a rechargeable, stand-alone unit that crushes up to 300 pills on one charge. To operate, users place a CompleteRX serving cup, medication, and the grinding cup into the unit, push a button, and mix the food into the powdered medication using the same cup. A demonstration can be viewed at http://www.firstwaveproducts.com/training.html. Nursing homes may obtain a complimentary test kit by contacting (877) 784–0269 or firstname.lastname@example.org.
Source.“First Wave Products Group Introduces First Crush.” (2013, January 9). Retrieved January 29, 2013, from http://www.jdcomm.biz/files/releases/First%20Crush%20Introductory%20Release.docx.
Interest Sought in Special Hospital Gown for Dementia Patients
InventHelp®, an inventor service company, has announced that one of its clients, an inventor from Wisconsin, has designed a hospital gown that would cover a disoriented or dementia patient’s intravenous (IV) site so that he or she does not tamper with the line and require a nurse or other qualified personnel to reinstall it. This invention is patented.
“Hospital IV Protector Gown” would consist of a cotton gown producible in hallway and bed-mate versions. Both versions would feature rear ties and long sleeves. Each sleeve would feature an open seam along its top that would secure shut via snaps. The knee-length hallway version would provide adequate coverage for modesty and warmth while ambulating in public. The shorter bed-mate version would feature a crescent back with a thin edge to avoid irritation or skin breakdown. After an IV has been connected to a patient’s arm, the nurse or other qualified personnel snaps the sleeve seam together so that the IV is out of sight and cannot be tampered with.
InventHelp is attempting to submit the invention to companies for review. If substantial interest is expressed, the company will attempt to negotiate for a sale or royalties for the inventor. For more information, call (800) 851–6030 (department 10-JMC-905) or visit http://www.inventhelp.com.
Source.InventHelp. (2012, November 29). “Hospital IV Protector Gown”—Modified Hospital Gown for Disoriented/Dementia Patients [Press release]. Pittsburgh, PA: Author.