Healthcare Industry News: pancreatitis
News Release - March 3, 2006
Low-Dose Regimens of Soriatane(R) (Acitretin) Effective in the Treatment of Moderate-to-Severe Plaque-Type PsoriasisNew Data Presented at AAD Shows Lower Doses of Soriatane Are Effective as Maintenance Therapy and Well-Tolerated
PALO ALTO, Calif.--(HSMN NewsFeed)--March 3, 2006--Connetics Corporation (Nasdaq:CNCT ), a specialty pharmaceutical company that develops and commercializes dermatology products, today announced that results of a Phase IV clinical study evaluating the long-term efficacy of a lower dosage of Soriatane® (acitretin) show that low-dose regimens of Soriatane over a six-month period are effective and well-tolerated in the treatment of adults with moderate-to-severe plaque-type psoriasis. A poster highlighting these results was presented today at the 64th Annual Meeting of the American Academy of Dermatology (AAD) in San Francisco.
"The current Soriatane treatment practice is to administer the maximum tolerable dose, ranging from 25 mg to 50 mg per day, while managing the dose-related side effect profile," said Jennifer Cather, MD, Modern Dermatology, Baylor University Medical Center, Dallas, Texas. "This has been the treatment protocol believed to achieve the greatest patient efficacy benefit. These study results are significant, because they demonstrate that administering Soriatane at the minimal, and therefore more tolerable, daily dosing regimen of 10 or 25 mg over a six-month period is as effective when compared to the more aggressive treatment regimen in practice today."
"With this study, we see that patients can begin initial therapy with a low-dose 25 mg regimen of Soriatane, experience a meaningful response with fewer side effects, and continue with that regimen into maintenance therapy where they can experience clearer skin and avoid flare-ups in the long-term management of their psoriasis," said Lincoln Krochmal, M.D., Executive Vice President of Research and Product Development for Connetics.
This poster is one of four presentations featured at AAD that evaluates Soriatane for the treatment of psoriasis.
New Efficacy Data with Low-Dose Regimen
The study was a Phase IV, multicenter, open-label, randomized study evaluating the long-term efficacy of a lower dosage of Soriatane in 77 psoriasis patients. Patients were randomized to receive either 25 mg of Soriatane once daily with food for 24 weeks (six months), or 25 mg of Soriatane once daily with food for 12 weeks followed by a "step down" dosing regimen of 10 mg once daily for 12 weeks.
The primary efficacy endpoints evaluated at weeks 12 and 24 included an Overall Lesional Assessment (OLA) of 0 or 1 (none or minimal), and Psoriasis Area and Severity Index (PASI) reduction of 50% and 75%. The secondary efficacy endpoint included a Subject's Global Assessment (SGA) of 0 or 1 (none or minimal). Dose reductions were allowed at weeks 0-24 at the investigators' discretion and dose increases up to 35 mg were allowed at week 12 if patients failed to achieve greater than or equal to 2 grade improvement in OLA. Efficacy and safety evaluations occurred often throughout treatment (baseline, weeks 2, 4, 8, 12, 20, and 24).
A majority of patients in both treatment arms completed the study (25 mg n=38; 25 mg/10 mg n=39). The daily mean Soriatane dose from baseline to week 12 was 25 plus/minus 2 mg in the 25 mg group and 25 plus/minus 1 mg in the 25 mg/10 mg group. The daily mean Soriatane dose between week 12 and 24 was 26 plus/minus 4 mg in the 25 mg group and 16 plus/minus 10 mg in the 25 mg/10 mg group.
In both treatment groups, study results show continued improvement at 12 and 24 weeks as evaluated by OLA. At week 12, 14 patients (18%) had none to minimal psoriasis and at week 24, 17 patients (45%) in the 25 mg group and 19 patients (49%) in the 25 mg/10 mg group had none to minimal psoriasis. Overall PASI 50 and PASI 75 response rates at week 12 were 38% and 14%, respectively. With continued Soriatane treatment, PASI 50 and PASI 75 response rates increased in patients maintaining the 25 mg dose and in patients whose dose was decreased to 10 mg after week 12. In both treatment arms, the percentage of patients reporting that their psoriasis was none to minimal at week 12 and week 24 was similar to that reported by the investigators. The side effects observed did not differ significantly between the two treatment groups.
Soriatane is a convenient, once-daily oral retinoid medication that is supplied in 10 mg and 25 mg capsules for the treatment of severe psoriasis in adults, including plaque, erythrodermic, pustular, guttate and palmar-plantar. Soriatane is the only oral once-a-day medication approved for both initial and maintenance treatment for severe psoriasis in adults.
Clinical efficacy studies show that 76% of patients with severe psoriasis who take Soriatane have statistically significant improvement in as little as eight weeks. At six months, 40% of patients experienced complete or almost complete clearing of their psoriasis; at 12 months, patients continued to experience statistically significant improvement in symptoms. Since Soriatane is neither immunosuppressive nor cytotoxic, it does not reduce a patient's resistance to common infections.
In women of childbearing potential, Soriatane should be reserved for patients who have not responded to other therapies or whose clinical condition makes other treatments inappropriate, because the drug may cause serious birth defects. Women who are pregnant or might become pregnant within three years after stopping therapy should not take Soriatane.
Other potentially serious adverse events that have been reported include liver toxicity, pancreatitis and increased intracranial pressure, as well as bone spurs, alteration in lipid levels, possible cardiovascular effects and eye problems. For product information on Soriatane, please call 1-888-500-DERM. For full prescribing information, including boxed contraindications and warnings, visit www.soriatane.com.
Psoriasis is a non-contagious genetic skin disease that affects approximately 5 million men and women in the United States. Researchers believe a certain type of white blood cell that usually protects the body against infection behaves in an abnormal way and causes skin cells to reproduce too quickly -- resulting in the flaking associated with psoriasis. Because of this affect on the body's immune system, psoriasis is considered to be an autoimmune disease.
People with psoriasis experience fluctuations in their symptoms. A varied combination of conditions and factors influence these changes: climate, infections, stress, dry skin and/or certain medicines.
The most common form of the disease, plaque psoriasis, appears as raised, red patches or lesions that are covered with a silvery white buildup of dead skin cells, called scale. Other types include guttate (small red spots on the skin), inverse (in armpits, groin and skin folds), pustular (white blisters surrounded by red skin), and erythrodermic (intense redness over large areas).
Approximately 1.5 million sufferers are categorized as moderate-to-severe patients. The National Psoriasis Foundation has set guidelines to determine the severity of a patient's psoriasis, which is measured by estimating the percentage of the body that is affected (e.g., moderate psoriasis is defined as 2-10%; severe psoriasis, more than 10%).
While there are a number of medications that may help control the symptoms of psoriasis, there is currently no cure. For more information on psoriasis, visit the National Psoriasis Foundation's web site at www.psoriasis.org.
Connetics Corporation is a specialty pharmaceutical company focused on the development and commercialization of innovative therapeutics for the dermatology market. Connetics has branded its proprietary foam drug delivery vehicle VersaFoam®. The Company's marketed products are OLUX® (clobetasol propionate) Foam, 0.05%, Luxiq® (betamethasone valerate) Foam, 0.12%, Soriatane® (acitretin) capsules and Evoclin® (clindamycin) Foam, 1%. Connetics is developing Desilux(TM) (desonide) VersaFoam-EF, 0.05%, a low-potency topical steroid formulated to treat atopic dermatitis; Primolux(TM) (clobetasol propionate) VersaFoam-EF, 0.05%, a super high-potency topical steroid formulation to treat atopic dermatitis and plaque psoriasis; Extina® (ketoconazole) VersaFoam-HF, 2%, to treat seborrheic dermatitis; and Velac® (a combination of 1% clindamycin and 0.025% tretinoin) Gel, for treating acne. Connetics' product formulations are designed to improve the management of dermatological diseases and provide significant product differentiation. In Connetics' marketed products, these formulations have earned wide acceptance by both physicians and patients due to their clinical effectiveness, high quality and cosmetic elegance. For more information about Connetics and its products, please visit www.connetics.com.
Forward Looking Statements
Except for historical information, this press release includes "forward-looking statements" within the meaning of the Securities Litigation Reform Act. All statements included in this press release that address activities, events or developments that Connetics expects, believes or anticipates will or may occur in the future, including, particularly, statements about Soriatane, are forward-looking statements. All forward-looking statements are based on certain assumptions made by Connetics' management based on its experience and perception of historical trends, current conditions, expected future developments and other factors it believes are appropriate in the circumstances. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond Connetics' control, and which could cause actual results or events to differ materially from those expressed in such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, risks and other factors that are discussed in documents filed by Connetics with the Securities and Exchange Commission from time to time, including Connetics' Annual Report on Form 10-K for the year ended December 31, 2004 and Form 10-Q for the quarter ended September 30, 2005. Forward-looking statements represent the judgment of the Company's management as of the date of this release, and Connetics disclaims any intent or obligation to update any forward-looking statements.
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