X
Pharma Advancement
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    development of new antibiotics

    EMA guidance supports development of new antibiotics

    Thermo Fisher Scientific Announces Collaboration with Northeastern University to Advance Biopharmaceutical Characterization and Monitoring Workflows

    Commercial Success In New Biopharmaceutical Innovation Era

    Proteros and AstraZeneca Boost Collaboration Agreement

    Conver to wp

    AbbVie and Cugene Join Forces Concerning Autoimmune Disorders and Cancer

    Drug Imagent For Therapeutic Platform

    Japan Pharma Lobby Says-Price Scheme Is Causing Drug Lag

    Charles River and Valence Discovery Announce Strategic Partnership to Provide Clients with AI-Enabled Drug Design Capabilities

    Charles River and Valo Launch Logica, an Integrated AI-Powered Drug Discovery Solution to Rapidly Deliver Optimized Preclinical Assets

    AstraZeneca announces phase IV ASCENT trial of Tudorza Pressair in patients with COPD meets primary efficacy endpoint

    AstraZeneca announces plans for new strategic R&D centre and Alexion headquarters in Cambridge, Massachusetts

    Lynparza approved in the EU for BRCA-mutated metastatic pancreatic cancer

    Major Success Factors For Clinical Development Organizations

    ArisGlobal Expands LifeSphere Clinical Portfolio with Landmark Customer Wins in APAC & Middle East

    ArisGlobal Expands LifeSphere Clinical Portfolio with Landmark Customer Wins in APAC & Middle East

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    development of new antibiotics

    EMA guidance supports development of new antibiotics

    Thermo Fisher Scientific Announces Collaboration with Northeastern University to Advance Biopharmaceutical Characterization and Monitoring Workflows

    Commercial Success In New Biopharmaceutical Innovation Era

    Proteros and AstraZeneca Boost Collaboration Agreement

    Conver to wp

    AbbVie and Cugene Join Forces Concerning Autoimmune Disorders and Cancer

    Drug Imagent For Therapeutic Platform

    Japan Pharma Lobby Says-Price Scheme Is Causing Drug Lag

    Charles River and Valence Discovery Announce Strategic Partnership to Provide Clients with AI-Enabled Drug Design Capabilities

    Charles River and Valo Launch Logica, an Integrated AI-Powered Drug Discovery Solution to Rapidly Deliver Optimized Preclinical Assets

    AstraZeneca announces phase IV ASCENT trial of Tudorza Pressair in patients with COPD meets primary efficacy endpoint

    AstraZeneca announces plans for new strategic R&D centre and Alexion headquarters in Cambridge, Massachusetts

    Lynparza approved in the EU for BRCA-mutated metastatic pancreatic cancer

    Major Success Factors For Clinical Development Organizations

    ArisGlobal Expands LifeSphere Clinical Portfolio with Landmark Customer Wins in APAC & Middle East

    ArisGlobal Expands LifeSphere Clinical Portfolio with Landmark Customer Wins in APAC & Middle East

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
Pharma Advancement
No Result
View All Result
Home Drug Development Clinical Trials

Recro Pharma Presents Phase III Bunionectomy Clinical Data For IV Meloxicam

Yuvraj_pawp by Yuvraj_pawp
16th May 2017
in Clinical Trials

Recro Pharma, Inc. , a revenue generating specialty pharmaceutical company focused on therapeutics for hospital and other acute care settings announced the presentation of clinical data from its Phase III study evaluating intravenous (IV) meloxicam 30mg for the treatment of acute postoperative pain in patients following bunionectomy surgery, at the American Pain Society 36th Annual Scientific Meeting, taking place May 17-20, 2017, in Pittsburgh, PA.

The poster presentation highlights the clinical performance of IV meloxicam 30mg, including achievement of the study’s primary endpoint, a statistically significant difference in Summed Pain Intensity Difference (SPID) over the first 48 hours (SPID48) compared to placebo, along with detailed secondary endpoints and safety results.


“The detailed Phase III results presented at the American Pain Society annual meeting highlight the clinical performance of IV meloxicam 30mg and the key features it can offer clinicians who are seeking non-opioid pain relief alternatives for their patients recovering from surgery,” said Stewart McCallum, M.D., F.A.C.S., Chief Medical Officer for Recro Pharma and co-author of the poster. “The data from this late-stage trial demonstrate that IV meloxicam 30mg provides rapid and sustained pain relief following bunionectomy surgery, a favorable safety and tolerability profile, and statistically significant differences in rescue use and numerous other pain relief metrics, including length of time to opioid rescue and number of patients utilizing opioid rescue analgesia, among others.”


Gerri Henwood, President and Chief Executive Officer of Recro, commented, “These exciting data demonstrate the key clinical attributes of IV meloxicam 30mg and support its potential as a new, non-opioid pain treatment option. If approved, IV meloxicam will be the only intravenously administered, once-daily, non opioid pain product and we believe it will play a meaningful role in the physician’s analgesic toolkit. The data from this pivotal clinical trial in bunionectomy, together with the positive results from our Phase III trial in patients following abdominoplasty surgery and the positive Phase III safety trial results reported last week, will form the basis of a New Drug Application (NDA) for IV meloxicam 30mg for the treatment of moderate-to-severe pain, which we plan to file with the U.S. Food and Drug Administration during early third quarter 2017.”


About IV/IM Meloxicam

Meloxicam is a long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory, and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase (COX) and subsequent reduction in prostaglandin biosynthesis. IV meloxicam was designed using a NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds.


About Recro Pharma, Inc.

Recro is a specialty pharmaceutical company that operates through two business divisions, an Acute Care, hospital product division and a revenue-generating contract development and manufacturing, or CDMO division, located at the Company’s Gainesville facility. The Acute Care division is primarily focused on developing innovative products for hospital and other acute care settings. The Company’s lead product candidate is a proprietary injectable form of meloxicam, a long-acting preferential COX-2 inhibitor. IV meloxicam has successfully completed four Phase II clinical trials in the management of moderate to severe post-operative pain and two pivotal Phase III clinical efficacy trials in patients following bunionectomy and abdominoplasty surgeries, as well as a large double blind Phase III safety trial and other safety studies.

As injectable meloxicam is in the non-opioid class of drugs, the Company believes it will overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well having no addictive potential while maintaining meaningful analgesic effects for relief of pain.

The Company’s CDMO division leverages its formulation expertise to develop and manufacture pharmaceutical products using its proprietary delivery technologies and other manufacturing services for commercial partners who commercialize or plan to commercialize these products. These collaborations can result in revenue streams including royalties, profit sharing, research and development and manufacturing fees, which support continued operations for its CDMO division and it contributes non-dilutive funding for the development and pre-commercialization activities of its Acute Care division.

CONTACT:

Media Contact:
Argot Partners
Eliza Schleifstein
(973) 361-1546
eliza@argotpartners.com


Investor Relations Contact:

Argot Partners
Susan Kim/Natalie Wildenradt
(212) 600-1902
susan@argotpartners.com
natalie@argotpartners.com

 

Recro Pharma, Inc.
Michael Celano
(484) 395-2413
mcelano@recropharma.com

Previous Post

Milestone Pharma Announces Etripamil Phase 2 Clinical Program Success for the Treatment of PSVT

Next Post

GE Healthcare’s FlexFactory to power Dr. Reddy’s biosimilar expansion plans

Related Posts

Lynparza approved in the EU for BRCA-mutated metastatic pancreatic cancer
Clinical Trials

Major Success Factors For Clinical Development Organizations

12th April 2022
ArisGlobal Expands LifeSphere Clinical Portfolio with Landmark Customer Wins in APAC & Middle East
Clinical Trials

ArisGlobal Expands LifeSphere Clinical Portfolio with Landmark Customer Wins in APAC & Middle East

8th April 2022
Takara Bio and Boston IVF Fertility Center Announce Partnership to Enable the Derivation of Clinical-grade hES cell lines for Cell Therapy Applications
Clinical Trials

Calyx Selected by ProTrials as Partner for Improving Clinical Trial Outcomes Data

22nd March 2022
Castor Launches CRO Partnership Program to Increase Adoption of Decentralized Clinical Trials
Clinical Trials

Castor Launches CRO Partnership Program to Increase Adoption of Decentralized Clinical Trials

7th February 2022
Astrazeneca Says Covid-19 Long-Acting Antibody Combination AZD7442 Rapidly Advances Into Phase III Clinical Trials
Clinical Trials

Valneva and Pfizer Report Further Positive Phase 2 Data for Lyme Disease Vaccine Candidate

7th February 2022
Qatar approves emergency use of Modernas COVID-19 vaccine
Clinical Trials

Moderna Starts Variant Specific Vaccine Trials After Pfizer

28th January 2022
Next Post

GE Healthcare’s FlexFactory to power Dr. Reddy’s biosimilar expansion plans

Latest News

Dupixent From Sanofi Delivers Another Fantastic Performance
Manufacturing

Sanofi Sets Up Fund To Enable Firms In Low-Income Countries

5th July 2022
GSK commences phase III study of Benlysta and rituximab combination in systemic lupus erythematosus
Manufacturing

Singapore Authorises New Ovarian Cancer Treatment By GSK

5th July 2022
Abbott Is Named Global Industry Leader in Sustainability for the Sixth Consecutive Year on the Dow Jones Sustainability Index (DJSI)
Manufacturing

Abbott India Affirms That The Medicines Are Not Their Own

5th July 2022
Global Biopharmaceutical Bioseparation Market Eyeing $20bn
Manufacturing

Global Biopharmaceutical Bioseparation Market Eyeing $20bn

4th July 2022
FDA Advises Adding Omicron BA.4, 5 To COVID-19 Boosters
Manufacturing

FDA Advises Adding Omicron BA.4, 5 To COVID-19 Boosters

4th July 2022
Pharma Advancement

About Us

Pharma Advancement is a leading Pharma information centric website. On one side Pharmaadvancement.com has established itself as one of the most efficient and comprehensive source of Pharma information online, dedicated to providing decision makers in all the Pharma industry sectors with reliable, accurate and useful insights into happenings in the Pharma sector.

Qucik Links

  • Drug Development
  • Manufacturing
  • News
  • Events & Conferences
  • Newsletter Archive

Resources

  • Advertise with us
  • Contact Us
  • Download Mediapack

System

  • Search
  • Sitemap
  • RSS Feed

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

No Result
View All Result
  • Home
  • Drug Development
  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

Login to your account below

Forgotten Password?

Fill the forms bellow to register

All fields are required. Log In

Retrieve your password

Please enter your username or email address to reset your password.

Log In