A new opiate pain medicine, Nucynta (tapentadol ), is available for IC pain. The manufacturer's website (http://www.nucynta.com/) notes that Nucynta inhibits transmission of pain impulses and pain signals on ascending pain pathways. In a study 602 patients reported pain relief within 32 to 46 minutes, on average. Nucynta has similar strength to Oxycodone, 100mg of Nucynta is equal to 15mg of Oxycodone. However, it is supposed to have fewer gastrointestinal side effects.
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Stellar Pharmaceuticals of Canada has signed a licensing agreement with Sigmar Italia, a specialty pharmaceutical sales and marketing company, for the distribution and sale of Uracyst in Italy.
Uracyst is a sodium chondroitin sulfate solution that is thought to work by replenishing the glycosaminoglycan (GAG) lining of the bladder (the protective barrier that guards the bladder against irritants and toxins in the urine).
While Uracyst is currently not FDA-approved for use in the United States, it is available in Canada and in several countries throughout Europe, and is awaiting regulatory approval in China and Israel.
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The International Journal of Clinical Practice features Diagnostic Options for Early Identification and Management of Interstitial Cystitis ⁄ Painful Bladder, in its December 2008 issue. Written by two renowned IC experts, John B. Forrest, MD, of Urologic Specialists of Oklahoma in Tulsa, and Robert M. Moldwin, MD, of the Smith Institute for Urology, New Hyde Park, New York, who is a member of the ICA’s Medical Advisory Board, this review article reaches a worldwide readership of clinicians.
The article discusses the merits of current IC diagnostic options including screening tools, cystoscopy with hydrodistention, bladder biopsy, the potassium sensitivity test, intravesical anesthetic challenge, urodynamics, and urinary markers. A section on IC treatment options is also included, and discusses oral medications, bladder instillations, dietary modification, and physical therapy.
Drs. Forrest and Moldwin emphasize the importance of early diagnosis and treatment, as well as good follow-up. They point out that early diagnosis and treatment can bring about better results for the patient, but that current available treatments can take time to work. They prescribe education, reassurance, and empowerment from the healthcare provider to encourage patients to participate in and stick with their treatment plan. They also argue that multimodal therapy with an emphasis on patient education can help ensure success in treating IC.
The article is available online and free-of-charge.
February 2009, Cafe ICA
The FDA approved Watson Pharmaceutical’s GELNIQUE (oxybutynin chloride) Gel 10% for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency. It is the first and only topical gel of its kind for OAB. The GELNIQUE Gel’s active ingredient, oxybutinin, a type of anticholinergic/antispasmodic commonly found in oral OAB treatments, is delivered through the skin (transdermally), thus reducing some of the bothersome side effects (dry mouth, constipation) known to occur with the use of oral anticholinergics. GELNIQUE is a quick-drying, clear and colorless, fragrance-free hydroalcoholic gel that is applied once daily to the thigh, abdomen, upper arm, or shoulder and delivers a consistent dose of oxybutynin through the skin over a 24-hour period. Because of GELNIQUE Gel’s high safety and tolerability during clinical studies, the medicine is now being considered first-line therapy for OAB.
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February 2009, Cafe ICA e-Newsletter
In January 2009, the FDA approved the antidepressant milnacipran (Savella) for the treatment of fibromyalgia, one of the frequently diagnosed related conditions in people with IC. In clinical trials, the drug reduced pain intensity by about 50 percent, and fatigue. A norepinephrine serotonin reuptake inhibitor (NSRI), Savella contains a higher ratio of norepinephrine to serotonin activity than serotonin-norepinephrine reuptake inhibitors (SNRIs), which is thought to make it more active against pain. Savella is the third prescription medicine to be FDA approved for the treatment of fibromyalgia. Pregabalin (Lyrica), an anticonvulsant, was approved in June 2007 and Cymbalta in June 2008. Savella has been available in Europe and Asia for many years, and is licensed by Pierre Fabre and Cypress Bioscience, Inc. and Forest Laboratories, Inc. A word of caution for people with IC: Dysuria (painful or difficult urination) is a possible side effect of Savella. Also, the effectiveness of these newer classes in IC is still being explored. Some patients report that these newer types of antidepressants, such as duloxetine (Cymbalta), escitalopram (Lexapro), bupropion (Wellbutrin), and sertraline (Zoloft), help their IC, while others report increased IC symptoms.
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January2009, Cafe ICA e-Newsletter
The need for standardized guidelines for diagnosing and treating IC has become very apparent over the past few years—and has generated many heated debates. The good news is that several countries and professional medical associations are now in the process of developing their own IC Guidelines.
Japanese Urological Association’s new IC Guidelines were recently published in the International Journal of Urology. Japanese Guidelines for Diagnosis and Treatment of Interstitial Cystitis by Homma, Ueda, Ito, Takei, and Tomoe is a very detailed, comprehensive document that you can access for free online. Members of the Society of Interstitial Cystitis of Japan developed the guidelines, which are endorsed by the Japanese Urological Association and aimed both urologists and other women’s healthcare professionals. The English translation in this journal is a shortened version of the Japanese guideline.
The Japanese IC Guidelines propose eventually adopting the new term “hypersensitive bladder syndrome” to describe IC symptoms and include IC patients with and without pain. The guidelines define IC as:
- lower urinary tract symptoms such as urinary frequency, bladder hypersensitivity, and/or bladder pain
- bladder pathology proven endoscopically by Hunner’s ulcer and/or mucosal bleeding after over-distention
- exclusion of confusable diseases such as infection, malignancy or calculi of the urinary tract
Because the IC definition includes abnormalities in the bladder, a diagnosis still requires cystoscopy and hydrodistention in Japan. Biopsy isn’t required, although it can help rule out cancer. But the authors were careful to recommend that biopsy should be done after hydrodistention to avoid bladder rupture. The guidelines call the potassium sensitivity test limited in diagnostic value because of the high rate of false negative and false positive results.
The American Urological Association (AUA) is currently working on IC guidelines for the United States with the goal of 2010 launch. ICA Executive Director Barbara Gordon and several of the ICA’s Medical Advisory Board are members of the AUA steering committee. We are hopeful that these various guidelines from different countries and professional associations will eventually lead to an international concensus regarding IC Guidelines.
August 2008, Café ICA e-Newsletter
On August 19, Urigen Pharmaceuticals announced that the US Patent and Trademark Office issued the first patent for the use of URG101, an investigational, bladder instillation treatment for painful bladder syndrome/interstitial cystitis (PBS/IC). Patent number US 7,414,039 broadly covers the use of the URG101 product in the treatment of PBS/IC. The term of the patent extends into 2025.
URG101 is a bladder instillation (requires catheterization) that consists of alkalinized lidocaine (an anesthetic) and heparin (thought to help to repair/soothe the bladder lining). The ingredients in URG101 have been mixed together to form bladder instillations for several years. Urigen's URG101 combines these two active ingredients in a premixed formula, making it more convenient for IC health providers.
Read more.
July 2008, Café ICA e-Newsletter
Advanced Neuromodulation Systems (ANS), a division of St. Jude Medical, Inc., recently announced US and European approvals of the Eon Mini, the world's smallest, longest-lasting rechargeable neurostimulator to treat chronic pain of the trunk or limbs and pain from failed back surgery. It should be available in both the US and Europe in late 2008.
The Eon Mini has the longest-lasting battery life of any rechargeable spinal cord stimulation (SCS) device in its class. It is the only small rechargeable neurostimulator to receive a 10-year battery longevity approval by the FDA. While not approved specifically for interstitial cystitis, neuromodulation devices such as this have been tried and tested in people with IC with varying degrees of success.
Visit these sites to learn more about Eon Mini:
July 2008, Café ICA e-Newsletter
In early July, Eli-Lilly announced that it received FDA approval for the use of the oral antidepressant Cymbalta (duloxetine) in treating fibromyalgia. Cymbalta belongs to a class of medications called selective SNRIs (serotonin and norepinephrine reuptake inhibitors) and is already FDA-approved for use in depression, generalized anxiety disorder, and diabetic neuropathy.
This is the second drug to be approved to treat fibromyalgia in just over a year, which is good news for those with IC who also have fibromyalgia, which is known to co-exist with IC. Pfizer’s Lyrica (pregabalin), an anticonvulsant which was the first-ever medication approved for use in fibromyalgia, received FDA approval in June of 2007.
For some people with IC, Cymbalta may cause urinary retention. In fact, it is approved in Europe to treat stress urinary incontinence in women (under the trade-name Yentreve), although at much higher doses than those recommended for fibromyalgia. For those who find this drug helpful for their IC and/or fibromyalgia, lower doses may help avoid any urinary side effects.
- For more information on Cymbalta, please click here.
- For more information on Lyrica, please click here.
Revised July 22, 2009