Phase III Randomized Control Trial Investigating Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting in Patients With Gynecologic Malignancies Receiving Every 3-week Carboplatin and Paclitaxel Chemotherapy

The objective of this study is to investigate the efficacy of olanzapine as compared to neurokinin-1 receptor antagonists (NK1-RAs) in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with gynecologic malignancies receiving single day outpatient chemotherapy (carboplatin and paclitaxel) every 3 weeks.

开始日期2020-12-28

申办/合作机构

Rogel Cancer Center: University of Michigan

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100 项与乙二磺酸丙氯拉嗪相关的专利（医药）

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项与乙二磺酸丙氯拉嗪相关的文献（医药）

2022-01-01·Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery4区 · 医学

Efficacy of outpatient infusion therapy in pediatric patients with postconcussive headaches

4区 · 医学

Article

作者: Gould, Sara ; Katz, Erin ; Cignetti, Carly ; McLeod, Chandler ; Mooney, James ; Pate, James

PURPOSE:

To determine the relative efficacy of intravenous therapy for postconcussive headaches in a pediatric population, as compared to oral therapy.

METHODS:

Pediatric patients treated for postconcussive headaches at an outpatient infusion clinic from 2016 to 2018 were selected for inclusion in the study. Of the 95 patients who were treated in clinic, 53 patients were selected for a retrospective chart review. Clinic visits before and after infusions were reviewed to determine changes in headache score (HA), symptom severity score (SSS), and self-reported symptom relief. An age-matched and SSS-matched group served as a control. The control group received only oral therapy for their headaches. The infusion consisted of parenteral ketorolac, compazine, diphenhydramine, and a normal saline bolus (20 mg/kg).

RESULTS:

Following infusion therapy, overall mean HA and SSS scores were both reduced (p < 0.0001). Oral therapy demonstrated a similar mean overall reduction in HA and SS scores (p < 0.0001). While both groups achieved a reduction in HA and SS scores, there was not a statistically significant difference in reduction of symptoms scores between the oral and infusion groups.

CONCLUSION:

Infusion therapy is as effective at reducing HA and SSS as established oral therapies. Infusion therapy may have a shorter time to headache abortion than oral therapy based on pharmacokinetics. Further, some physicians are unwilling to allow an athlete to return to play while taking suppressive medication. Future studies may show that an infusion could allow a more rapid return to play and resolution of symptoms.

2018-01-01·American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists4区 · 医学

Stability of extemporaneously prepared preservative-free prochlorperazine nasal spray

4区 · 医学

Article

作者: Yellepeddi, Venkata K.

PURPOSE:

The stability of an extemporaneously prepared preservative-free prochlorperazine 5-mg/mL nasal spray was evaluated.

METHODS:

The preservative-free prochlorperazine nasal spray was prepared by adding 250 mg of prochlorperazine edisylate to 50 mL of citrate buffer in a low-density polyethylene nasal spray bottle. A stability-indicating high-performance liquid chromatography (HPLC) method was developed and validated using the major degradant prochlorperazine sulfoxide and by performing forced-degradation studies. For chemical stability studies, 3 100-μL samples of the preservative-free prochlorperazine from 5 nasal spray bottles stored at room temperature were collected at days 0, 20, 30, 45, and 60 and were assayed in triplicate using the stability-indicating HPLC method. Microbiological testing involved antimicrobial effectiveness testing based on United States Pharmacopeia (USP) chapter 51 and quantitative microbiological enumeration of aerobic bacteria, yeasts, and mold based on USP chapter 61. Samples for microbiological testing were collected at days 0, 30, and 60.

RESULTS:

The stability-indicating HPLC method clearly identified the degradation product prochlorperazine sulfoxide without interference from prochlorperazine. All tested solutions retained over 90% of the initial prochlorperazine concentration for the 60-day study period. There were no detectable changes in color, pH, and viscosity in any sample. There was no growth of bacteria, yeast, and mold for 60 days in all samples tested.

CONCLUSION:

An extemporaneously prepared preservative-free nasal spray solution of prochlorperazine edisylate 5 mg/mL was physically, chemically, and microbiologically stable for 60 days when stored at room temperature in low-density polyethylene bottles.

2013-03-01·Journal of Palliative Medicine

Clearing Bowel Obstruction and Decreasing Pain in a Terminally Ill Patient via Manual Physical Therapy

Letter

作者: Patterson, Kimberley ; Reed, Evette D'Avy ; Rice, Amanda D. ; Wurn, Belinda F. ; Wurn, Lawrence J.

Decreasing pain and improving function and quality of life are important topics for patients that refuse, or are not candidates for traditional medical interventions, and those at end stages of disease. Patients with inoperable, metastatic bowel carcinoma that experience pain and small bowel obstruction (SBO) as a result of adhesions are a subset of these patients. The standard treatment, adhesion and/or resection surgery followed by post-surgical medications to prevent infection and decrease pain, may not be ideal in end-stage cancer patients. We treated such a patient using a manual soft tissue physical therapy with goals of decreasing her pain and alleviating symptoms of bowel obstruction secondary to adhesions successfully, using a protocol we developed initially to open fallopian tubes that were blocked by adhesions. The patient was a 61-year-old married woman with a history of multiple abdominopelvic surgeries over the last 12 years including hysterectomy, ileostomy and ileostomy reversal with chemotherapy and radiation for treatment of stage IIIB ovarian/peritoneal carcinoma. She experienced SBO episodes every 2-3 months and had five adhesiolysis and/or resection surgeries to attempt to repair the bowel. Because she had undergone a recent exploratory laparoscopy that revealed metastasis to the omentum, her physicians were reluctant to perform any further surgeries, and the patient requested no more surgical interventions. She was unable to eat or drink, so a peripherally inserted central catheter (PICC line) was placed, and she received total parenteral nutrition (TPN) daily. She experienced chronic pain associated with the SBOs at a level of 4-5/10 that increased throughout the day with movement. The patient was undergoing chemotherapy, and medicated with Nexium 40mg qd, Compazine 10mg prn, Zofran 4mg prn, Ativan 1mg qd, multivitamin bid, Vitamin D 2000mg qd, Co-Enzyme Q10 qd and Dilaudid prn for pain. Her goals were to relieve the abdominal pain, decrease SBO incidents, eat a normal diet and travel.

项与乙二磺酸丙氯拉嗪相关的新闻（医药）

2022-08-29

·BioSpace

ANI Pharmaceuticals Announces the Launch of Prochlorperazine Maleate Tablets USP

Aug. 29, 2022 10:50 UTC BAUDETTE, Minn.--(BUSINESS WIRE)-- ANI Pharmaceuticals, Inc. (“ANI” or the “Company”) (Nasdaq: ANIP) today announced the launch of Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg. ANI’s Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg are the generic version of the Reference Listed Drug (RLD) Compazine® and were developed in technical collaboration with Biophore India Pharmaceuticals Pvt. Ltd. (“Biophore”). The current annual U.S. market for Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg is approximately $30.0 million, according to IQVIA/IMS Health, a leading healthcare data and analytics provider. “We are pleased to bring Prochlorperazine, another limited competition product to the market and provide customers and patients access to high quality generics,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI. "In keeping with our mission of providing affordable, high quality options for patients; we are pleased to partner with ANI on the launch of this limited competition product,” stated Dr. Jagadeesh Rangisetty, Chief Executive Officer of Biophore. About ANI ANI Pharmaceuticals, Inc. is a diversified biopharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need. Our team is focused on delivering sustainable growth by building a successful Purified Cortrophin® Gel franchise, strengthening our generics business with enhanced development capability, innovation in established brands and leveraging our North American manufacturing capabilities. For more information, please visit our website . About Biophore India Pharmaceuticals Pvt. Ltd. Biophore, an established pharmaceutical company, is engaged in the development and manufacturing of niche, high quality pharmaceutical products for the generic industry. Since its inception in 2007, Biophore has emerged as a trusted partner for niche and complex products in the generic industry across US, Europe and other regulated markets. For more information, please visit our website, . Forward-Looking Statements To the extent any statements made in this release deal with information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, those relating to the commercialization and potential sales of the product and any additional product launches from the Company’s generic pipeline, other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “plans,” “potential,” “future,” “believes,” “intends,” “continue,” other words of similar meaning, derivations of such words and the use of future dates. Uncertainties and risks may cause the Company’s actual results to be materially different than those expressed in or implied by such forward-looking statements. Uncertainties and risks include, but are not limited to, the risk that the Company may face with respect to importing raw materials; competition from other products; acquisitions; contract manufacturing arrangements; delays or failure in obtaining and maintaining product approval from the U.S. Food and Drug Administration; general business and economic conditions; market trends; products development and commercialization; regulatory and other approvals and marketing. More detailed information on these and additional factors that could affect the Company’s actual results are described in the Company’s filings with the Securities and Exchange Commission (SEC), including its most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other filings with the SEC. All forward-looking statements in this news release speak only as of the date of this news release and are based on the Company’s current beliefs, assumptions, and expectations. The Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. All brand names listed are the registered trademarks of their respective owners.

仿制药并购

2022-07-18

·BioSpace

Generic Injectables Sales Are Poised To Flourish At A CAGR Of 13.3% To Reach A Value Of US$ 3.6 Billion By The End Of 2032, states Fact.MR

Increasing Prevalence & Expensive Cost of Cancer Treatment Offers Significant Boost in Generic Therapeutics Demand The large molecular injectables segment is projected to capture lion’s share in the global generic injectables market, accounting for 3/5th of the total market value Fact.MR – A Market Research and Competitive Intelligence Provider: The global generic injectables market would be worth US$ 1.02 Bn in 2022 and have a double-digit CAGR of 13.3% between 2022 and 2032. Fact.MR states that with an ever-increasing demand for large-size molecular injectables, the global Generic injectables market is projected to reach US$ 3.6 Bn by the year 2032. Demand for Large Molecular injectables will continue to thrive, with a documented CAGR of 34.8% during the 2015-2021 historical period of assessment, while demand for Generic Injectables in Oncology proliferated at a rate of 11.5% during the same period. The APAC will dominate the global market, registering a growth opportunity worth US$ 20.8 Million from 2022 to 2032. Oncology is into adoption of generic injectables. This demand is expected to grow at the rate of 11.5% in the forecast period. For Critical Insights on this Market, Request for More Info at: Key Takeaways from Market Study North America, led by the US, is expected to hold the largest market share, expanding at the rate of 14.3% between 2022 and 2032. Europe is riding on Baxter, which, along with Dorizoe, has developed over 20 generic injectable products inclusive of oncolytic and cardiovascular medicines. The Asia-Pacific is expected to grow at the fastest pace due to increase in frequency of outsourcing research activities to CROs. Key Drivers Stimulating Generic Injectables Industry Expansion The global generic sterile injectable market is principally propelled by the mounting prevalence of several chronic diseases like cancer, diabetes, and the increasing geriatric population across the globe. Developing branded formulations is a time-consuming and expensive process. The average time required to develop a new chemical entity is a decade. A cost of US$ 5-8 Billion is incurred in the development of drug formulations, owing to stringent government regulations that ensure the safety and efficacy of preclinical and clinical trials. Shortage of supply for numerous critical medicines, especially the injectable form of drugs that are mainly used in cancer chemotherapy, is a foremost problem faced globally. Due to constant scarcities, patients are unable to gain access to basic life-saving drugs, and this dearth is likely to sternly affect the expansion of the market. Fact.MR estimates that the valuation of the generic injectables market is likely to reach US$ 250 Million by 2032 which evaluated nearly US$ 75 Million in 2021. Projections indicate a robust CAGR of 11.4% during the forecast period. The treatment of cardiovascular diseases includes nanoparticle-based drug delivery as an ideal therapeutic alternative. This aspect is also responsible for augmenting the growth of the injectable drug delivery system in the region. To Gain In-Depth Insights on Generic Injectables Market, Request Methodology at Market Developments The key participants are moving in the direction of fostering flawless client-customer relationship. Hospira, Inc., in April 2022, announced acquiring Orchid Chemicals & Pharmaceuticals Ltd.’s business pertaining to generic injectable phaarmaceuticals for close to US$ 400 Bn. The Buena, of late, ended up paying US$ 500,000 to AstraZeneca in cash for 17 injectables, 18 products, and aa topical. It is also about to make milestone payments of close to US$ 6 Bn. In Feb 2022, the company did pay royalty of almost US$ 3 Bn. Cosette Pharmaceuticals Inc., in February 2022, did launch Prochlorperazine Edisylate injection. It’s generic equivalent to Compazine injection 10 mg/2 ml. This drug does help in curbing vomiting as well as severe nausea. The other usage is treatment of schizophrenia. Key Segments Covered in the Generic Injectables Industry Survey Generic Injectables by Product type Large Molecule Injectables mAb Generic Injectables Insulin Generic Injectables Other Generic Injectables Small Molecule Injectables Generic Injectables by Application Generic Injectables for Oncology Generic Injectables for Infectious Disease Generic Injectables for Cardiology Generic Injectables for Diabetes Generic Injectables for Immunology Others Generic Injectables by Container Type Vials Ampoules Premix Prefilled syringes Other Generic Injectables by Region North America Generic Injectables Market Latin America Generic Injectables Market Europe Generic Injectables Market Asia Pacific Generic Injectables Market Middle East & Africa Generic Injectables Market For Comprehensive Insights Ask An Analyst Here More Valuable Insights Available Fact.MR, in its new offering, presents an unbiased analysis of the global generic injectables market, presenting historical market data (2017-2021) and forecast statistics for the period of 2022-2032. The study reveals essential insights by product type (large molecule injectables, mAb generic injectables, insulin generic injectables, small molecule injectables, and other generic injectables), by application (oncology, infectious disease, generic injectables for cardiology (diabetes, immunology, and others)), by container type (vials, ampoules, premix, prefilled syringes, and likewise), and by region (North America, LATAM, Europe, East Asia, South Asia & Oceania, and MEA). Explore Fact.MR’s Coverage on the Healthcare Domain Bone Grafts and Substitutes Market - Bone Grafts and Substitutes Market By Product (Allografts, Synthetic Bone Grafts), By Material (Ceramic-based, Polymer-based, Growth Factor-based, Cell-based), By End User (Hospitals, Orthopedic Clinics) & Region - Global Market Insights 2021 to 2028 Medical Waste Management Market - Medical Waste Management Market Forecast, Trend Analysis & Competition Tracking - Global Market Insights 2020 to 2025 Gene Therapy Market - Gene Therapy Market Forecast, Trend Analysis & Competition Tracking - Global Market Insights 2020 to 2026 Drug Delivery Systems Market - Drug Delivery Systems Market Forecast, Trend Analysis & Competition Tracking - Global Market Insights 2020 to 2025 Antibody Drug Conjugates Contract Market - Antibody Drug Conjugates Contract Market by Condition Type (Myeloma, Lymphoma, Breast Cancer, Other Condition Types), Application Type (Cleavable Linker, Non-cleavable Linker), and By Region- 2022 to 2032 Cochlear Implant Market - Cochlear Implant Market by Fitting Type (Unilateral Implants, Bilateral Implants), End Use (Adult, Pediatric), and Region (North America, Latin America, Europe, APAC, and MEA) from 2022 to 2032 Lateral Flow Assays Market - Lateral Flow Assay Market by Product Type (Lateral Flow Readers, Digital/Mobile Readers, Benchtop Readers, Kits & Reagents), Application (Drug Development & Quality Testing, Clinical Testing etc.), Technique End-use, and Region -2022 to 2032 Ophthalmic Ultrasound Devices Market - Ophthalmic Ultrasound Devices Market by Product (B-Scan, A-Scan, Combined, Pachymeter, Ultrasound Bio Microscope), By Mobility (Portable, Standalone), By End Use (Hospitals, Ambulatory Surgery Centers, Ophthalmology Clinics, Others), and by Region - 2022 to 2032 Reprocessed Medical Devices Market - Reprocessed Medical Devices Market Analysis by Device Type (Cardiovascular Devices, General Surgery Devices, Laparoscopic Devices, Orthopedic External Fixation Devices, Gastroenterology Biopsy Forceps), by Region - Global Forecast 2021-2028 Coronary Stents Market - Coronary Stents Market Analysis By Product (Bare Metal Stents, Drug Eluting Stents, Bio-absorbable Stents) & Region - Global Forecast 2021 to 2028 About Us: Market research and consulting agency with a difference! That’s why 80% of Fortune 1,000 companies trust us for making their most critical decisions. While our experienced consultants employ the latest technologies to extract hard-to-find insights, we believe our USP is the trust clients have on our expertise. Spanning a wide range – from automotive & industry 4.0 to healthcare & retail, our coverage is expansive, but we ensure even the most niche categories are analyzed. Our sales offices in United States and Dublin, Ireland. Headquarter based in Dubai, UAE. Reach out to us with your goals, and we’ll be an able research partner. Contact: Mahendra Singh US Sales Office: 11140 Rockville Pike Suite 400 Rockville, MD 20852 Email: sales@factmr.com Tel: +1 (628) 251-158

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KEGG	Wiki	ATC	Drug Bank
D02609	乙二磺酸丙氯拉嗪	N05AB04	-

研发状态

适应症	最高研发状态	国家/地区	公司
精神分裂症	撤市	美国更多	GlaxoSmithKline, Inc. 更多

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03435003 (CTgov)	临床4期	术后恶心呕吐 \| 呕吐	83	dexmedetomidine+Total intravenous anesthesia+scopolamine transdermal+Compazine+sugammadex+Reglan+Propofol+Fentanyl+Ondansetron+Aprepitant 80 mg Oral Capsule+Dexamethasone (Intervention Arm)	膚鑰網鏇觸繭繭窪壓衊(淵糧選範網膚獵繭壓糧) = 廠膚積築繭顧襯鏇網鏇製壓構襯鏇遞壓網選憲 (鹹廠網選膚鏇鑰壓夢繭, 膚觸積選淵廠遞鹹鹽網 ~ 艱襯鹹網網顧鏇構齋衊) 更多	-	2024-02-14
				Compazine+sugammadex+Reglan+Sevoflurane+Desflurane+Ondansetron+Dexamethasone (Control Arm)	膚鑰網鏇觸繭繭窪壓衊(淵糧選範網膚獵繭壓糧) = 夢艱獵選鹹艱積選積襯製壓構襯鏇遞壓網選憲 (鹹廠網選膚鏇鑰壓夢繭, 鹹鑰壓醖鹽壓衊衊壓網 ~ 窪鬱壓鹹鑰簾網製鏇糧) 更多