YARDLEY, PA–(Marketwire – 10/21/10) – Eurand Pharmaceuticals, Inc., a accessory of all-around specialty biologic aggregation Eurand N.V. (NASDAQ:EURX – News), today appear added abstracts from a post-hoc assay of a Phase III analytic balloon with ZENPEP® (pancrelipase) Delayed-Release Capsules, an FDA-approved pancreatic agitator artefact (PEP) for the assay of exocrine pancreatic dearth (EPI) in patients with cystic fibrosis (CF) or added conditions. The abstracts is actuality presented today at the 24th Anniversary North American Cystic Fibrosis Conference in Baltimore, Md.Results of a post-hoc assay from the randomized, double-blind, placebo-controlled crossover abstraction of 34 patients authenticate that ZENPEP provided a cogent and accelerated advance of signs and affection of EPI in CF patients switched from their antecedent PEPs, after added assurance on proton pump inhibitors (PPIs) and H2 receptor antagonists. Twenty of the 34 patients (58%) were demography PPIs or H2 antagonists above-mentioned to abstraction access and discontinued them afterward accepting in the study. PPIs and H2s are assigned to ascendancy belly acid.”These allegation may advance the abeyant for abbreviation us accountability for patients with EPI due to CF,” said Ruth Thieroff-Ekerdt, M.D., Chief Medical Officer, Eurand Pharmaceuticals. “Patients can apprehend ZENPEP to accommodate ascendancy of signs and affection as aboriginal as day 2 of treatment, behindhand of their accessory medication with belly acerbic modifiers. H2 antagonists and PPIs are frequently taken accordingly with PEPs to advance their efficacy.”Study ResultsIn a Phase III randomized, double-blind, placebo-controlled abstraction of 34 patients with EPI due to CF, ZENPEP resulted in decidedly college accessory of fat assimilation (a key indicator of comestible assimilation in patients with CF) compared to placebo. Enrolled patients discontinued PPIs/H2 antagonists and were switched from antecedent PEPs to ZENPEP during a dose-titration and stabilization aeon according to evidence ascendancy of EPI for six to nine canicule above-mentioned to randomization (ZENPEP or placebo). In a post-hoc analysis, a absolute evidence account basis (TSI) was affected from patient-reported signs and affection of stool consistency, bloating, flatulence, pain, and arresting oil in stool.At commensurable doses, patients accomplished cogent and accelerated evidence advance during the stabilization aeon back switched from antecedent PEPs (mean dosage 5,100 U lipase/kg/day) to ZENPEP (mean dosage 4,600 U lipase/kg/day). Evidence improvement, as abstinent by the TSI, was empiric as aboriginal as day 2 and was cogent at day 4 (P=0.017). There were no cogent differences in TSI array amid patients ahead apparent to PPIs/H2 antagonists and those who were not ahead apparent to PPIs/H2 antagonists. ZENPEP was able-bodied acceptable in all assay periods, including the stabilization period, and its assurance contour was constant with those of added PEPs.ZENPEP has been evaluated in analytic studies in adults and accouchement as adolescent as one year old. ZENPEP is offered in four dosage strengths — 5,000, 10,000, 15,000 and 20,000 units of lipase — to acquiesce for absolute dosing and for potentially bargain us burden, and to accommodated the assorted needs of infants, toddlers, adolescents and adults with EPI. In addition, the capacity of ZENPEP capsules may be opened and brindled on bendable acerb foods such as angel sauce. This acceptable advantage is a key aspect to abode the needs of patients who may accept adversity burning capsules, such as absolute adolescent patients or assertive earlier patients.About Exocrine Pancreatic Dearth (EPI)Exocrine Pancreatic Dearth (EPI) is the disability to appropriately abstract aliment due to a abridgement of digestive enzymes fabricated by the pancreas. EPI can aftereffect from a cardinal of diseases, including cystic fibrosis, pancreatic cancer, gastrointestinal surgery, and abiding pancreatitis. The FDA estimates that added than 200,000 Americans ache from EPI. If larboard untreated, EPI causes malnutrition and, abnormally in CF patients, broken advance in children, compromised allowed acknowledgment and beneath action expectancy.Important Assurance InformationZENPEP has been accustomed with a Accident Evaluation and Mitigation Strategy (REMS) to ensure that the allowances of the biologic outweigh its risks. As allotment of the REMS, a Medication Guide with important dosing and assurance advice about ZENPEP will be handed out with anniversary new decree and refill.The REMS and Medication Guide abode the accident associated with the use of ZENPEP, including fibrosing colonopathy, a rare, austere adverse acknowledgment that has been appear afterward assay with high-dose use of pancreatic agitator backup assay in the assay of cystic fibrosis patients. The absolute circadian dosage of ZENPEP should not beat 10,000 lipase units/kg of anatomy weight/day, and attention should be acclimated with doses beyond 2,500 lipase units/kg of anatomy weight per meal. Also, there is a abstract accident of manual of viral disease, back ZENPEP, as added porcine-derived pancreatic enzymes, is sourced from pancreatic tissue from barbarian acclimated for aliment consumption. No cases of manual of an communicable affliction associated with the use of beefy pancreatic extracts accept been reported.Care should be taken to ensure that ZENPEP is not chewed or retained in the aperture to abstain affliction of articulate film and/or accident of agitator activity, and the capsules or chaplet should be swallowed anon with able amounts of liquid. Attention should be acclimatized back application ZENPEP in patients with gout, renal impairment, or hyperuricemia; porcine-derived pancreatic agitator articles may access claret uric acerbic levels. Attention should be acclimatized for patients with accepted allergies to proteins of beefy origin. In attenuate instances, astringent allergic reactions including anaphylaxis, asthma, hives, and pruritus accept been appear with added pancreatic agitator articles with altered formulations of the aforementioned alive ingredient, pancrelipase, as that of ZENPEP.In analytic trials assessing the concise assurance of ZENPEP, the accident of adverse contest (regardless of causality) was agnate during double-blind ZENPEP assay and placebo treatment. The best frequently appear adverse contest occurring in at atomic two patients (greater than or according to 6% of patients) included: belly pain, flatulence, headache, cough, decreased weight, aboriginal satiety, and contusion. The blazon and accident of adverse contest were agnate in accouchement and adults.For complete advice about safety, warnings and precautions for ZENPEP, amuse see abounding Prescribing Advice and Medication Guide at www.zenpep.com.About EurandEurand is a specialty biologic aggregation that develops, articles and commercializes added biologic and biopharmaceutical articles based on its proprietary biologic technologies. Eurand has had six articles accustomed by the FDA back 2001 and has a action of artefact candidates in development for itself and its accord partners. Its technology platforms accommodate bioavailability accessory of ailing acrid drugs, custom absolution profiles and taste-masking orally aition book (ODT) formulations. Eurand is a all-around aggregation with accessories in the U.S. and Europe. For added information, appointment www.eurand.com.Forward-Looking StatementThis absolution and articulate statements fabricated with account to advice independent in this release, including statements about the bazaar abeyant of ZENPEP, aggregate advanced statements. Such advanced statements accommodate those which accurate plan, anticipation, intent, contingency, goals, targets or approaching development and/or contrarily are not statements of absolute fact. The words “expects,” “potentially,” “anticipates,” “could,” “calls for” and agnate expressions additionally analyze advanced statements. These statements are based aloft management’s accepted expectations and are accountable to risks and uncertainties, accepted and unknown, which could account absolute after-effects and developments to alter materially from those bidding or adumbrated in such statements. Factors that could affect absolute after-effects include, risks associated with our adeptness to market, commercialize and accomplish bazaar accepting for ZENPEP or to advance or accomplice any of our added articles and the ambiguity surrounding the timing of the FDA’s approval for Axcan’s ULTRASE® MT. A non-exclusive account of important factors that may affect approaching after-effects may be begin in Eurand’s filings with the Securities and Exchange Commission, including its anniversary abode on Form 20-F and alternate letters on Form 6-K. Investors should appraise any account in ablaze of these important factors. Advanced statements independent in this columnist absolution are fabricated as of this date, and we undertake no obligation to about amend any advanced statement, whether as a aftereffect of new information, approaching contest or otherwise. Absolute contest could alter materially from those advancing in the advanced statements.
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