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FDA Panel Votes on Prucalopride for Continual Idiopathic Constipation

Posted in News on 21st October 2018
The Committee reviewed data from an observational pharmacoepidemiology safety study which estimated the risk of MACE

The Committee reviewed data from an observational pharmacoepidemiology safety study which estimated the risk of MACE

The Food and Drug Administration (FDA)’s Gastrointestinal Drugs Advisory Committee voted in favor (10 to 0) of approving prucalopride for the treatment of chronic idiopathic constipation (CIC) in adults.

Prucalopride, a selective 5-hydroxytryptamine (serotonin) type 4 receptor (5-HT4) agonist, is a gastrointestinal (GI) prokinetic agent that stimulates colonic peristalsis, increasing bowel motility. It has been studied in over 90 clinical trials over the past 20 years and is currently approved in 82 countries. If approved in the US, it would be the only 5-HT4 receptor agonist indicated for CIC.

The panel’s decision was made based on data from from five Phase 3 studies and one Phase 4 trial which evaluated the safety and efficacy of prucalopride in patients with chronic constipation. The Committee also reviewed results from an observational pharmacoepidemiology safety study (N=35,000) which estimated the risk of major adverse cardiovascular events (MACE) in new users of prucalopride vs polyethylene glycol 3350 (PEG). The study was conducted to address safety concerns regarding the potential for cardiovascular risk with 5-HT4 agonists being developed for GI motility disorders. In this mostly female patient population (>90%), the pooled adjusted incidence rate ratio for MACE was 0.64 (95% CI, 0.36, 1.14).

A Prescription Drug User Fee Act (PDUFA) date for prucalopride has been set for December 21, 2018. The FDA is not bound by the Committee’s recommendation but takes it into consideration when making its decision.

Ultromics expands a number of medical trials for coronary coronary heart illness to the U.S.

Posted in News on 20th October 2018

Ultromics, the U.Okay. start-up behind the world’s first outcomes pushed, AI-based, ultrasound diagnostic assist device for coronary artery illness (CAD), is presently supporting a number of ongoing medical trials.

These trials embrace “Rainier”, based mostly within the U.S., and “EVAREST”, which is increasing throughout 35 NHS websites throughout the U.Okay.

Each trials deal with the analysis of coronary artery illness utilizing Ultromics’ first product, EchoGo. Outcomes are anticipated throughout the subsequent few months and will likely be submitted to the FDA with the intention of acquiring clearance on the market throughout the U.S.

The U.S. based mostly Rainier trial features a retrospective evaluate of 550 stress exams, in addition to a complete of 1,600 heart specialist reads from quite a lot of ability ranges.

The primary part of the trial is situated at Oregon Well being and Science College (OHSU) and is being completed at the side of main cardiologists Dr. Sanjiv Kaul, Director of the Knight Cardiovascular Institute, and Dr. Stephen Heitner, Director of the Hypertrophic Cardiomyopathy Clinic.

The U.Okay. based mostly EVAREST trial – administered by the Oxford Cardiovascular Scientific Analysis Facility on the College of Oxford – has efficiently entered Section III.

Section III will ship recruitment of 5,000 contributors throughout 35 NHS websites, making it one of many largest echo research within the U.Okay.

This part sees continued recruitment from Section II, with 11 new websites and an extra 15 websites presently present process feasibility evaluation to hitch in early 2019. This may permit for the generalisability of stress echo protocols, machine sorts, operators, and affected person teams throughout totally different healthcare settings.

On the conclusion of those trials, Ultromics intends to show that EchoGo is the world’s most correct echocardiography-based device for the analysis of CAD.

Historically, clinicians use echocardiograms to diagnose a affected person’s situation based mostly on only a few components, which ends up in an correct analysis roughly 80% of the time beneath the very best circumstances. EchoGo, however, makes use of deep studying and one of many world’s largest echo picture databases.

It helps clinicians by delivering larger accuracy in each sensitivity and specificity and will save healthcare payers and suppliers vital quantities by decreasing the incidence of sufferers present process pointless surgical procedures.

Simply as considerably, it might probably save lives by stopping sufferers with probably deadly coronary heart illness from being despatched house.

Coronary heart illness is the largest killer globally. Of the three million stress exams carried out within the US every year, it’s estimated round 600,000 could also be misinterpret.

That is probably costing the US healthcare business billions of in pointless extra prices.

We’re decided to supply sufferers and suppliers with a dependable analysis, which in flip will create vital enchancment to affected person outcomes and financial savings for healthcare programs.”

Ross Upton, CEO and Founder at Ultromics

Supply:

http://www.ultromics.com/information/ultromics-expands-coronary-artery-disease-trials-to-the-u-s-to-establish-largest-ongoing-clinical-trial-programme-of-its-kind/

Rituxan Labeling Up to date With Observe Up Remedy Data for Sufferers With GPA/MPA

Posted in News on 20th October 2018

October 19, 2018

Rituxan is a CD20-directed cytolytic antibody

Rituxan is a CD20-directed cytolytic antibody

The Food and Drug Administration (FDA) has approved updated labeling for Rituxan (rituximab; Genentech) to include information on follow up treatment for patients with granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) who have achieved disease control with induction therapy. Rituxan, a CD20-directed cytolytic antibody, was initially approved for GPA and MPA, in combination with glucocorticoids, in 2011.

The approval for follow up treatment was based on data from an open-label, prospective, active-controlled study (MAINRITSAN) involving 115 patients in disease remission (86 with GPA, 24 with MPA, 5 with renal-limited ANCA-associated vasculitis). Patients were randomized to receive azathioprine or rituximab; the primary endpoint of the study was the occurrence of major relapse, defined by the reappearance of clinical or laboratory signs of vasculitis activity that could lead to organ failure or damage, or could be life-threatening, through month 28.

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Results showed the observed cumulative incidence rate of first major relapse during the 28 months was lower in patients treated with rituximab compared with azathioprine (5% vs 29%, respectively). In addition, the safety profile was found to be consistent with that previously seen in this patient population.

“Options for continued treatment in GPA and MPA, chronic autoimmune diseases in which patients experience periods of flares, are currently limited,” said Sandra Horning, MD, chief medical officer and head of Global Product Development. “As part of our commitment to support people living with rare diseases, we are pleased to provide updated prescribing information for Rituxan to help physicians make more informed decisions about therapeutic options for patients who have achieved disease control with induction treatment.”

For more information visit Gene.com.

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Purdue Pharma, Eisai announce constructive topline outcomes from Part three examine of lemborexant

Posted in News on 19th October 2018

Eisai Co., Ltd. and Purdue Pharma L.P. introduced constructive topline outcomes from SUNRISE 2, a long-term Part three efficacy and security analysis of lemborexant, an investigational agent for sleep-wake regulation at the moment being studied for the potential remedy of a number of sleep-wake problems. Topline outcomes reported right this moment are the first and key secondary outcomes of the examine from the six-month, placebo-controlled remedy interval; the examine is ongoing to 12 months. Eisai and Purdue Pharma plan to current full outcomes from SUNRISE 2 at upcoming medical conferences in 2019.

SUNRISE 2 enrolled greater than 900 grownup sufferers (18 to 88 years of age) with insomnia dysfunction, characterised by issue falling asleep and/or staying asleep. The examine met the pre-specified main and key secondary efficacy goals assessed by affected person self-reports (sleep diaries). On the finish of the six-month, placebo-controlled remedy interval, lemborexant 5 mg and 10 mg offered statistically vital enchancment in subjective sleep onset latency in comparison with placebo, the examine’s main endpoint. Lemborexant 5 mg and 10 mg additionally offered statistically vital enchancment in sleep upkeep variables of subjective sleep effectivity and subjective wake after sleep onset in comparison with placebo, which have been the examine’s key secondary endpoints. Day by day functioning, as measured by the Insomnia Severity Index, was additionally improved by each lemborexant 5 mg and 10 mg in comparison with placebo. General discontinuation charges on account of AEs have been comparable between placebo and lemborexant 5 mg, and better for lemborexant 10 mg.

“As a clinician and researcher treating sufferers with insomnia and different sleep-wake problems for 30 years, for me, profitable remedy signifies that sufferers go to sleep quick, sleep nicely, and wake nicely, with out practical impairment, or lack of impact over time,” stated Russell Rosenberg, PhD, D.ABSM, a Principal Investigator within the lemborexant research and former Chairman of the Board of the Nationwide Sleep Basis. “The outcomes of SUNRISE 2 are notably encouraging for the numerous sufferers that suffer from persistent insomnia.”

The outcomes of SUNRISE 2 construct on a rising physique of information supporting the event of lemborexant, together with SUNRISE 1, a zolpidem tartrate prolonged launch in addition to key security research evaluating for impairment as assessed by the power to keep up postural stability – a predictor of danger for falls – after middle-of-the-night and subsequent morning awakening and next-morning driving efficiency.

“Our aspiration for lemborexant is to carry to the hundreds of thousands of sufferers affected by insomnia and different sleep- wake problems an agent for sleep-wake regulation that improves their capacity to go to sleep and keep asleep, and maintains efficacy over time,” stated Lynn Kramer, MD, Chief Medical Officer and Chief Medical Officer, Neurology Enterprise Group, Eisai. “In SUNRISE 2, lemborexant improved time to sleep onset and sleep upkeep over a six-month interval. With these outcomes, we now look ahead to continuing with regulatory submissions for lemborexant to carry to sufferers a long-term remedy possibility for treating the sleep-wake dysfunction, insomnia.”

Lemborexant seems to impression the underlying motive for a affected person’s incapability to sleep nicely. Lemborexant acts on the orexin neurotransmitter system and is believed to control sleep and wake by dampening wakefulness with out impeding the power to awaken to exterior stimuli.
“These lemborexant examine outcomes for sleep onset and sleep upkeep are important elements of the sleep-wake paradigm for these affected by insomnia,” stated Marcelo Bigal, MD, PhD, Chief Medical Officer, Purdue Pharma. “We perceive the significance of sleep-wake regulation to general well being and affected person outcomes and, alongside our collaboration companion, Eisai, look ahead to continued analysis as a part of our dedication to a wide range of affected person populations with sleep-wake problems.”

Found by Eisai, lemborexant is being collectively developed by Eisai and Purdue Pharma. Details about ongoing medical research is obtainable at clinicaltrials.gov.

This launch discusses investigational makes use of of an agent in improvement and isn’t supposed to convey conclusions about efficacy or security. There is no such thing as a assure that such investigational agent will efficiently full medical improvement or achieve well being authority approval.

Supply:

https://www.eisai.com/information/2018/information201885.html

AGA: New Opioid-Induced Constipation Administration Tips Obtainable

Posted in News on 19th October 2018

October 18, 2018

The recommendations have been published in the AGA's official journal, Gastroenterology

The recommendations have been published in the AGA’s official journal, Gastroenterology

The American Gastroenterological Association (AGA) has issued new guidelines on the medical management of opioid-induced constipation (OIC). The recommendations have been published in the AGA’s official journal, Gastroenterology.

“These guidelines presume that patients have been appropriately diagnosed and that they have either a prolonged requirement or dependence on opioids,” write the authors. “Therefore, one of the first steps to managing patients with OIC is to ensure that the indication for opioid therapy is appropriate, that patients are participating in a pain management program (ideally in conjunction with a pain specialist), and that they are taking the minimum necessary opioid dose.”

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The recommendations were developed using GRADE (Grading of Recommendations Assessment, Development, and Evaluation) methodology, with a strong recommendation indicating that most patients should receive the recommended course of action; a conditional recommendation would mean that different choices may apply depending on the patient, and a clinician may need to spend extra time to work toward a decision.

In the management of OIC, the new guidelines state the following:

  • In patients with OIC, the use of laxatives as first-line agents is recommended (Strong; moderate-quality evidence)
  • In patients with laxative refractory OIC, naldemedine is recommended over no treatment (Strong; high-quality evidence)
  • In patients with laxative refractory OIC, naloxegol is recommended over no treatment (Strong; moderate-quality evidence)
  • In patients with laxative refractory OIC, methylnaltrexone is suggested over no treatment (Conditional; low-quality evidence)
  • The AGA makes no recommendation for the use of lubiprostone in OIC (No recommendation; evidence gap)
  • The AGA makes no recommendation for the use of prucalopride in OIC (No recommendation; evidence gap)

Addressing their recommendations on newer agents (intestinal secretagogues, selective 5-HT agonists), the guideline panel writes that given the lack of published data on long-term use, additional studies are needed to establish the benefits of these drugs.

“Physicians have struggled with treating this condition due to previous lack of clinical guidance,” said Seth D. Crockett, MD, MPH, lead author of the guideline, University of North Carolina School of Medicine, Chapel Hill. “The new AGA guideline clarifies existing data and provides clear direction for physicians on how to best treat opioid-induced constipation.”

For more information visit gastrojournal.org.

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