The purpose of this study is to look at two standard surgical techniques used during a radical cystectomy and see whether they influence outcomes such as length of stay in the hospital and infections after surgery. This trial will evaluate whether the following surgical methods influence outcomes:
A ureteral stent is a thin tube that is placed in your ureter to drain urine from your kidney. Ureteral stents are often used to promote urine drainage after radical cystectomy, but may come at risk of urinary tract infection.
Alvimopan is a standard drug used to promote return of bowel function following surgery. Doctors do not know whether alvimopan is beneficial in current clinical practice.
The surgeon will decide whether participants will receive a stent and/or alvimopan, but if they are unsure what the best approach is, a surgical technique has been assigned by chance to them.

Start Date21 Nov 2024

Sponsor / Collaborator

Memorial Sloan Kettering Cancer Center

NCT04405037

/ RecruitingPhase 4IIT

A Prospective Randomized Control Trial of The Effectiveness of Alvimopan as a Rescue Treatment of Postoperative Ileus Following Colorectal Surgery

This study aims to evaluate the cost effectiveness of Alvimopan as rescue therapy in patients undergoing colorectal or small bowel resection who develop POI, and its safety and effectiveness in reducing LOS and POI duration.
This will be a prospective randomized control trial with a total of 58 patients, 29 in each group. Patients who undergo laparoscopic or open colorectal resection, small bowel resection, or ileostomy reversal with small bowel resection that subsequently develop postoperative ileus will be eligible for enrollment. If they meet inclusion/exclusion criteria, they will be randomized at the time of diagnosis of postoperative ileus to receive Alvimopan as rescue therapy or to receive conservative standard care.
Patients randomized to the study group will be given a maximum of 3 doses of Alvimopan 12mg orally, 12 hours apart. Alvimopan will be given from the time of diagnosis of postoperative ileus to the time of return of bowel function or the maximum 3 doses. Subsequent Alvimopan doses will be given if there is no return of bowel function or if symptoms of distension and/or nausea persist despite some return of bowel function.

Start Date01 Aug 2020

Sponsor / Collaborator

The Cleveland Clinic Foundation

NCT03216525

/ RecruitingPhase 3IIT

A Randomized, Double-blind, Single-Center Trial of Alvimopan (Entereg) Versus Placebo in Patients Undergoing Radical Cystectomy and Urinary Diversion on an Enhanced Recovery After Surgery ERAS Protocol

To determine if Alvimopan during open or robotic radical cystectomy with urinary diversion results in quicker return of bowel function (GI-2 recovery = time to upper [first toleration of solid food] and lower [first bowel movement] gastrointestinal recovery) compared to placebo.

Start Date01 Oct 2018

Sponsor / Collaborator

The Brigham & Women's Hospital, Inc.

[+1]

100 Clinical Results associated with Alvimopan Dihydrate

100 Translational Medicine associated with Alvimopan Dihydrate

100 Patents (Medical) associated with Alvimopan Dihydrate

251

Literatures (Medical) associated with Alvimopan Dihydrate

01 Nov 2024·Medicine

Recovery of gastrointestinal functional after surgery for abdominal tumors: A narrative review

Review

Author: Ma, Liang ; Zhong, Jian-Hong ; Xie, Gui-Sheng

Postoperative gastrointestinal dysfunction, including temporary nonmechanical suppression of gastrointestinal motility (known as postoperative ileus), occurs in about 10% surgeries of abdominal tumors. Since these complications can prolong hospitalization and affect eating, it is important to understand their risk factors and identify effective interventions to manage or prevent them. The present review comprehensively examined the relevant literature to describe risk factors for postoperative ileus and effective interventions. Risk factors include old age, open surgery, difficulty of surgery, surgery lasting longer than 3 hours, preoperative bowel treatment, infection, and blood transfusion. Factors that protect against postoperative ileus include early enteral nutrition, minimally invasive surgery, and multimodal pain treatment. Interventions that can shorten or prevent such ileus include minimally invasive surgery, early enteral nutrition as well as use of chewing gum, laxatives, and alvimopan. Most of these interventions have been integrated into current guidelines for enhanced recovery of gastrointestinal function after surgery. Future high-quality research is needed in order to clarify our understanding of efficacy and safety.

30 Sep 2024·Rozhledy v chirurgii

Postoperative ileus and possibilities of pharmacological intervention

Review

Author: Urbánek, Libor ; Urbánková, Pavla ; Trávníček, Tomáš

Introduction: Postoperative ileus is a severe condition occurring especially in high-risk patients following acute and prolonged surgical procedures. Multiple factors are described as important in etiology, such as inflammation as well as neurological, hormonal and pharmacological influences. In prevention and treatment, we try to apply non-pharmaceutical procedures, to influence reversible etiological factors and, in postoperative period, to implement and use ERAS procedures. Drugs are the other possibility how to influence this pathology. Short-term impairment of intestinal motility following the most of the intraabdominal surgeries must be also taken in count in the differential diagnosis and treatment. Study aim: We try to describe all possibilities of pharmacological treatment and prevention of the postoperative ileus. Effectiveness of drugs used in present praxis, especially group of so-called prokinetics is analyzed. Conclusion: Postoperative ileus is still recognized as severe complication. Pharmacological treatment options are limited, only a few substances have evident positive impact (neostigmin for treatment and alvimopan – not registered in the Czech Republic for prevention). More evidence is necessary for positive effect of 5-hydroxytryptamine 4 (5HT4) agonists, and the effect of selective COX-2 inhibitors is still controversial.

14 Jun 2024·Medicine

An outline of the management and prevention of postoperative ileus: A review

Review

Author: Iskander, Othman

Postoperative ileus (POI) is a prevalent surgical complication, which results in prolonged hospitalization, patient distress, and substantial economic burden. The literature aims to present a brief outline of interventions for preventing and treating POI post-surgery. Data from 2014 to 2023 were gathered from reputable sources like PubMed, PubMed Central, Google Scholar, Research Gate, and Science Direct. Inclusion criteria focused on studies exploring innovative treatments and prevention strategies for POI, using keywords such as novel POI treatments, non-pharmacological prevention, POI incidence rates, POI management, and risk factors. The findings revealed that integration of preventive measures such as coffee consumption, chewing gum, probiotics, and use of dikenchuto within enhanced recovery programs has significantly reduced both the frequency and duration of POI, without any adverse effects, with minimally invasive surgical approaches showing promise as an additional preventive strategy. While treatment options such as alvimopan, NSAIDs, and acupuncture have demonstrated efficacy, the use of lidocaine has raised concerns due to associated adverse effects. The ongoing exploration of novel therapeutic strategies such as targeting the mast cells, vagal nerve stimulation and tight junction protein, and prokinetic-mediated instigation of the cholinergic anti-inflammatory trail not only holds promise for enhanced treatment but also deepens the understanding of intricate cellular and molecular pathways underlying POI. POI presents a complex challenge in various surgical specialties, necessitating a multifaceted management approach. The integration of preventive and treatment measures within enhanced recovery programs has significantly reduced POI frequency and duration.

News (Medical) associated with Alvimopan Dihydrate

02 Jul 2024

·www.prnewswire.com

Innocan Pharma Engages Pain Management Expert in Preparation for Upcoming FDA Meeting

HERZLIYA, Israel and CALGARY, Alberta , July 2, 2024 /PRNewswire/ -- Innocan Pharma Corporation (CSE: INNO) (FSE: IP4) (OTCQB: INNPF) ("Innocan" or the "Company"), a pioneer in the pharmaceutical and biotechnology industries, is pleased to announce that it has engaged Past-President of the Eastern Pain Association, Dr. William K. Schmidt, to support its LPT-CBD submission process to the FDA for chronic pain. "We are thrilled to have Dr. Schmidt as part of our LPT-CBD submission expert team," said Iris Bincovich, CEO of Innocan. "His extensive expertise in pain-related clinical development and regulatory affairs will strongly contribute to our LPT-CBD submission process with the FDA. His expertise significantly strengthens our team as we work towards FDA approval." Dr. Schmidt brings over 25 years of pharmaceutical industry clinical trial experience, specializing in analgesic and narcotic antagonist drug development. He has held key positions at several pharmaceutical companies, including CrystalGenomics, Limerick BioPharma, Renovis, Inc., Adolor Corporation, and DuPont Merck. At Adolor, Dr. Schmidt played a crucial role in the development and FDA approval of Entereg® (alvimopan), a peripherally acting opioid antagonist. At CrystalGenomics, Dr. Schmidt led the clinical team that lead to the approval of Acelex® (polmacoxib) in South Korea. At DuPont / DuPont Merck, Dr. Schmidt played key roles in the development of nalbuphine (Nubain®), naltrexone (Trexan®, ReVia®) and the oxycodone-ibuprofen formulation used in Combunox™. Currently, as head of NorthStar Consulting, he advises pharmaceutical and biotech companies globally on pain medicine development. Dr. Schmidt received a BA from the University of California Berkeley, and received his PhD from the University of California San Francisco. About Innocan Pharma: Innocan is a pharmaceutical tech company that operates under two main segments: Pharmaceuticals and Consumer Wellness. In the Pharmaceuticals segment, Innocan focuses on developing innovative drug delivery platform technologies comprises with cannabinoids science, to treat various conditions to improve patients' quality of life. This segment involves two drug delivery technologies: (i) LPT CBD-loaded liposome platform facilitating exact dosing and the prolonged and controlled release of CBD into the blood stream. The LPT delivery platform research is in the preclinical trial phase for two indications: Epilepsy and Pain Management. In the Consumer Wellness segment, Innocan develops and markets a wide portfolio of innovative and high-performance self-care products to promote a healthier lifestyle. Under this segment Innocan has established a Joint Venture by the name of BI Sky Global Ltd. that focuses developing on advanced targeted online sales. NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE. Caution Regarding Forward-Looking Information Certain information set forth in this news release, including, without limitation, the Company's plans for human trials of its LPT-CBD platform, is forward-looking information within the meaning of applicable securities laws. By its nature, forward-looking information is subject to numerous risks and uncertainties, some of which are beyond Innocan's control. The forward-looking information contained in this news release is based on certain key expectations and assumptions made by Innocan, including expectations and assumptions concerning the anticipated benefits of the products, satisfaction of regulatory requirements in various jurisdictions and satisfactory completion of production and distribution arrangements. Forward-looking information is subject to various risks and uncertainties that could cause actual results and experience to differ materially from the anticipated results or expectations expressed in this news release. The key risks and uncertainties include but are not limited to: global and local (national) economic, political, market and business conditions; governmental and regulatory requirements and actions by governmental authorities; and potential disruption of relationships with suppliers, manufacturers, customers, business partners and competitors. There are also risks that are inherent in the nature of product distribution, including import/export matters and the failure to obtain any required regulatory and other approvals (or to do so in a timely manner). The anticipated timeline for entry to markets may change for a number of reasons, including the inability to secure necessary regulatory requirements, or the need for additional time to conclude and/or satisfy the manufacturing and distribution arrangements. As a result of the foregoing, readers should not place undue reliance on the forward-looking information contained in this news release. A comprehensive discussion of other risks that impact Innocan can be found in Innocan's public reports and filings which are available under Innocan's profile at . Readers are cautioned that undue reliance should not be placed on forward-looking information as actual results may vary materially from the forward-looking information. Innocan does not undertake to update, correct or revise any forward-looking information as a result of any new information, future events or otherwise, except as may be required by applicable law. Logo: Contact Information: For Innocan Pharma Corporation: Iris Bincovich, CEO +1 5162104025 +972-54-3012842 +442037699377 [email protected] SOURCE Innocan Pharma Corporation

Drug ApprovalExecutive Change

12 Jan 2021

·www.biospace.com

Leading BioSciences Announces Positive Topline Data from Open-Label Gastrointestinal Surgery Study

CARLSBAD, Calif., Jan. 08, 2021 (GLOBE NEWSWIRE) -- Leading BioSciences, Inc. (“LBS”), a privately held company that recently entered into a definitive agreement for a reverse merger with Seneca Biopharma, Inc. (Nasdaq:SNCA) to form Palisade Bio, Inc. announced today that data from an open-label study demonstrated that patients treated with LB1148 had a statistically significant shorter length of stay in the hospital than the expected length of stay based on their billing code at admission. “We believe these early data, although in a limited number of patients, support our ongoing Phase 2 clinical trial to evaluate the impact of LB1148 on return to bowel function and length of stay,” said Michael Dawson, MD, Chief Medical Officer of LBS. “This reduction in hospital length of stay can be quite meaningful for both hospitals and patients in today’s medical setting. We look forward to presenting the full results from this study at a medical meeting later this year.” The data are from an open-label, investigator-sponsored, single-arm study that enrolled 11 patients and evaluated 10 patients undergoing elective gastrointestinal (“GI”) surgery. Upon admission, patients are typically assigned a billing code that is associated with an expected geometric mean length of stay (“GMLOS”). The GMLOS is derived from hundreds of thousands of admissions and represents an expected mean length of stay. The actual length of stay of patients treated with LB1148 in this clinical trial was compared to the expected GMLOS. LB1148 treated patients had a statistically significant reduction in hospital length of stay by 1.3-days when compared with expected length of stay based on their billing code at admission. The improvement in length of stay observed in LB1148-treated patients compared favorably to that previously reported from clinical trials of ENTEREG® which were between 0.3 days and 0.7 days. Following GI surgery, postoperative return of bowel function is often a limiting determinant of hospital discharge. The mean time for a first bowel movement in LB1148-treated patients in this clinical trial following surgery was 2.43 days. As a reference, in a clinical trial of the approved-drug, ENTEREG®, which enrolled a similar elective bowel resection surgery patient population, the mean time for first bowel movement in the placebo treated patients was 4.7 days. Results were previously disclosed in the company’s December 17, 2020 conference call. Full results for the open-label GI study are expected to be disclosed at an upcoming conference in 2021. About Leading BioSciences, Inc. Leading BioSciences is developing novel therapeutics designed to improve human health through therapeutic protection of the gastrointestinal mucosal barrier. LBS’ initial focus is combatting the interruption of GI function (ileus) following major surgery in order to reduce recovery times and shorten the duration of patient hospital stays. Additionally, LBS believes that its investigational therapies have the potential to prevent the formation of postoperative adhesions (reducing hospital re-admissions and additional surgeries), as well as to address the myriad health conditions and complications associated with chronic disruption of the gastrointestinal mucosal barrier. As of December 2020, Leading BioSciences has entered into a definitive agreement with Seneca Biopharma, Inc. under which a wholly owned subsidiary of Seneca will merge with Leading BioSciences in an all-stock transaction. The combined company is expected to operate under the name Palisade Bio, Inc. (Nasdaq: PALI), upon completion of the merger. No Offer or Solicitation: This communication will not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor will there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities in connection with the proposed merger shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended. Important Additional Information Will be Filed with the SEC In connection with the proposed transactions between LBS and Seneca, Seneca filed a registration statement on Form S-4 that contained a proxy statement and prospectus with the Securities Exchange Commission (“SEC”) on December 23, 2020, but the registration statement has not yet become effective. This communication is not a substitute for the registration statement or the proxy statement or any other documents that Seneca may file with the SEC or send to its stockholders in connection with the proposed transactions. BEFORE MAKING ANY VOTING DECISION, SENECA URGES INVESTORS AND STOCKHOLDERS TO READ THESE MATERIALS CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT SENECA, THE PROPOSED TRANSACTION AND RELATED MATTERS. You may obtain free copies of the registration statement, proxy statement and all other documents filed or that will be filed with the SEC regarding the proposed transaction at the website maintained by the SEC at . The registration statement is available free of charge on Seneca’s website at , by contacting Seneca’s Investor Relations by phone at (301) 366-4960, or by electronic mail at investor@senecabio.com. Investors and stockholders are urged to read the registration statement, proxy statement, prospectus and the other relevant materials when they become available before making any voting or investment decision with respect to the proposed transaction. Participants in the Solicitation Seneca and LBS, and each of their respective directors and executive officers and certain of their other members of management and employees, may be deemed to be participants in the solicitation of proxies in connection with the proposed transaction. Information about Seneca’s directors and executive officers is included in Seneca’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on March 27, 2020, and the proxy statement for Seneca’s 2020 annual meeting of stockholders, filed with the SEC on June 24, 2020. Additional information regarding these persons and their interests in the transaction is included in the proxy statement relating to the transaction. These documents can be obtained free of charge from the sources indicated above. Cautionary Statement Regarding Forward-Looking Statements This communication contains “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements related to the timing and results of clinical trials, and other statements that are not historical facts. Any statements contained in this communication that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as “expect,” “intend,” “plan,” “anticipate,” “believe,” “will,” and similar expressions and their variants. These forward-looking statements are based upon LBS’s current expectations. Forward-looking statements involve risks and uncertainties, and actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. Except as required by law, LBS expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in LBS’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. Leading BioSciences Media Relations Contact: Darren Opland, Ph.D. LifeSci Communications darren@lifescicomms.com Leading BioSciences Investor Relations Contact: Corey Davis, Ph.D. LifeSci Advisors cdavis@lifesciadvisors.com Corporate Contact: Justin Stege, Ph.D. justin.stege@leadingbiosciences.com

CollaborateAcquisition

21 May 2008

·www.biospace.com

Adolor Corporation to Host Investor Conference Call to Discuss the FDA Approval of Entereg(R) (alvimopan)

EXTON, Pa.--(BUSINESS WIRE)--Adolor Corporation (NASDAQ:ADLR) will be hosting an investor conference call and webcast on Wednesday, May 21, 2008 at 8:30 a.m. Eastern Time to discuss the U.S. Food and Drug Administration (FDA) approval of Entereg® (alvimopan) capsules to help patients regain gastrointestinal function earlier following bowel resection surgery.

100 Deals associated with Alvimopan Dihydrate

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KEGG	Wiki	ATC	Drug Bank
D02878	Alvimopan Dihydrate	A06AH02	DB06274

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Ileus	Phase 2	US	GSK Plc	01 Mar 2001
Ileus	Phase 2	US	Cubist Pharmaceuticals LLC	01 Mar 2001
Postoperative ileus	Phase 2	US	GSK Plc	01 Mar 2001
Postoperative ileus	Phase 2	US	Cubist Pharmaceuticals LLC	01 Mar 2001

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02742181 (CTgov)	Phase 3	Ileus \| Postoperative ileus	14	Alvimopan (Alvimopan Group)	(lapxswjvxi) = gpalcbjzum epgvxyedvo (ordzkzayqv, elfyytkqku - vnrbuglthz) View more	-	18 Nov 2022
				Control Group (Control Group)	(lapxswjvxi) = lrlptsddpm epgvxyedvo (ordzkzayqv, vpkvkfltdv - nyakgssfaa) View more
NCT03352414 (Pubmed \| J Am Coll Surg)	Phase 2	-	62	Alvimopan	wccecidhpo(khynjejkys) = gzmfawbcqz rvutumshhc (vtvwswduiq, 102 - 158) View more	Positive	23 Jun 2022
				Placebo	wccecidhpo(khynjejkys) = mehwulcsuz rvutumshhc (vtvwswduiq, 134 - 204) View more
AUA2022	Not Applicable	Bladder Cancer	86	Alvimopan	mtcxiifwgc(viotivsjsn) = qitihwzqmd dkvoqisypy (qvcthiwucn ) View more	-	01 May 2022
				Naloxegol	mtcxiifwgc(viotivsjsn) = uykogwcson dkvoqisypy (qvcthiwucn ) View more
NCT03352414 (ILEUS, CTgov)	Phase 2	Ileus	84	Alvimopan (Alvimopan)	oszubkohej(kbfassajuw) = lntkxeplgk rbtmsbeihw (cwkwapmjak, tlfimexhqr - epdkqxoscr) View more	-	01 Jul 2021
				Placebo (Placebo)	oszubkohej(kbfassajuw) = caxilavyvt rbtmsbeihw (cwkwapmjak, bodbumclte - rlyaqggjcw) View more
NCT02789111 (CTgov)	Phase 4	Constipation	49	Alvimopan (Alvimopan)	(rwprljnuwu) = pnygohnqlj rpbimyfrzt (juxwwoatbv, sncofogpql - tmepcgduze) View more	-	01 Dec 2020
				Placebo (Placebo)	(rwprljnuwu) = fdndesnbry rpbimyfrzt (juxwwoatbv, wupntpuzcq - pwkaogmogp) View more
NCT02379858 (CTgov)	Not Applicable	Hernia, Ventral	10	Alvimopan (Alvimopan (Entereg))	epbetxkikh(ekkthgrcoq) = gixcrbazrq ugznpcbeme (jmdqlehjxz, rmshyebqqc - eauzexwhtm) View more	-	29 Oct 2019
				Placebo (Suger Pill (Control))	epbetxkikh(ekkthgrcoq) = yzdkscqhxn ugznpcbeme (jmdqlehjxz, gxsccycrew - dwofhvduci) View more
NCT02218190 (CTgov)	Not Applicable	Ileus \| Spinal fusion	31	Alvimopan (Alvimopan)	xmubijzcfm(ypwqofjdpg) = vimbwzrppn nzowbtvbrr (pkiidqjwbi, sflgakmufc - eeiojhngpe) View more	-	17 May 2019
				Placebo (Placebo - Sugar Pill)	xmubijzcfm(ypwqofjdpg) = djlpafztsz nzowbtvbrr (pkiidqjwbi, bpggbixshk - cfpsydguuk) View more
AUA2019	Not Applicable	-	1,087	Alvimopan	djgziewbrb(xadykezyey) = qvmehhgetu rjqqgwfwfj (unnkowetpu )	-	01 Apr 2019
ASCO_GU2017	Not Applicable	Testicular Neoplasms	29	Alvimopan	shqnmpwdag(fkxhezaljh) = kspebbpkqf axdwzqezet (hynunsvkau ) View more	Positive	29 Mar 2017
				No Alvimopan	shqnmpwdag(fkxhezaljh) = kkqnevicvm axdwzqezet (hynunsvkau ) View more
NCT01704651 (CTgov)	Phase 3	Ovarian Cancer \| Primary peritoneal carcinoma \| Fallopian Tube Carcinoma	146	Alvimopan (Alvimopan)	bddxsoaknn(cmlipsgqol) = rvtktzitfa ectntwpbgh (xozqpugant, wpzpnoalqb - lsesqsrxbb) View more	-	24 Oct 2016
				Placebo (Placebo)	bddxsoaknn(cmlipsgqol) = fojhykozto ectntwpbgh (xozqpugant, yehkskbaos - myczrhleef) View more

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