Oxicam

Nanoform initiates GMP campaign for first-in-human trial of nanoformed drug by year end - ahead of schedule

Retrieved on: 
Tuesday, October 20, 2020
Health, Nonsteroidal anti-inflammatory drugs, Pharmaceutical sciences, Medicinal chemistry, Pyridines, Clinical pharmacology, Hepatotoxins, Piroxicam, Oxicam, Pharmaceutical industry, Pharmaceutical formulation, Bioavailability

The clinical trial is a progression of Nanoform's first GMP campaign, which the company has now initiated, and will be made in partnership with Quotient Sciences ("Quotient"), a leading provider of drug development and manufacturing solutions.

Key Points: 
  • The clinical trial is a progression of Nanoform's first GMP campaign, which the company has now initiated, and will be made in partnership with Quotient Sciences ("Quotient"), a leading provider of drug development and manufacturing solutions.
  • In the clinical trial, Nanoform will investigate the behavior of an oral immediate release (IR) nanoformedformulation of piroxicam, an anti-inflammatory drug.
  • Nanoform will manufacture the nanoformed piroxicam active pharmaceutical ingredient (API), which will then be transferred to Quotient's facilities in Nottingham, UK.
  • Quotient will support the project by developing a standard drug formulation for the nanoformed piroxicam API and administering it to healthy volunteers.

Heron Therapeutics Announces Successful Outcome of FDA Type A Meeting to Discuss HTX-011 for the Management of Postoperative Pain

Retrieved on: 
Tuesday, September 8, 2020
Drugs, Health, Nonsteroidal anti-inflammatory drugs, RTT, Food and Drug Administration, Veterinary drugs, Pharmaceutical industry, Meloxicam, Bupivacaine, New Drug Application, Oxicam, Local anesthetic

HTX-011 is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam.

Key Points: 
  • HTX-011 is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam.
  • Heron submitted a new drug application (NDA) to the FDA for HTX-011in October 2018 and received Priority Review designation in December 2018.
  • A complete response letter (CRL) was received from the FDA regarding the NDA for HTX-011 on June 26, 2020 relating to nonclinical information.
  • Heron is developing novel, patient-focused solutions that apply its innovative science and technologies to already-approved pharmacological agents for patients suffering from pain or cancer.

Baudax Bio Announces Presentation of New Phase IIIb ANJESO® Data at the American Society of Colon and Rectal Surgeons 2020 Annual Scientific Meeting

Retrieved on: 
Thursday, July 30, 2020
Nonsteroidal anti-inflammatory drugs, Drugs, RTT, Boehringer Ingelheim, Meloxicam, Thiazoles, ASCRS, Oxicam

MALVERN, Pa., July 30, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced a virtual poster presentation highlighting new Phase IIIb ANJESO(meloxicam) injection clinical data at the American Society of Colon and Rectal Surgeons (ASCRS) 2020 Annual Scientific Meeting.

Key Points: 
  • MALVERN, Pa., July 30, 2020 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced a virtual poster presentation highlighting new Phase IIIb ANJESO(meloxicam) injection clinical data at the American Society of Colon and Rectal Surgeons (ASCRS) 2020 Annual Scientific Meeting.
  • These positive results will inform our future physician education initiatives as we support the ongoing commercial launch of ANJESO.
  • The virtual presentation describes clinical outcomes from a randomized, placebo-controlled Phase IIIb study evaluating preoperative doses of ANJESO in 55 patients undergoing bowel resection and/or anastomosis.
  • The incidence of individual adverse events (AEs) were comparable between groups or numerically lower in the meloxicam IV group.

Baudax Bio Announces PDUFA Date for Intravenous Meloxicam

Retrieved on: 
Wednesday, January 22, 2020
Nonsteroidal anti-inflammatory drugs, Health, Drugs, Meloxicam, Prescription Drug User Fee Act, COX-2 inhibitor, Analgesic, Food and Drug Administration, Oxicam, Opioid

The assignment of this PDUFA goal date follows the FDAs acceptance of Baudaxs latest complete response package relating to its 2019 complete response letter (CRL) and appeal filing, seeking approval for IV meloxicam.

Key Points: 
  • The assignment of this PDUFA goal date follows the FDAs acceptance of Baudaxs latest complete response package relating to its 2019 complete response letter (CRL) and appeal filing, seeking approval for IV meloxicam.
  • We will be working closely with the FDA as they complete their review of the IV meloxicam NDA and work toward the PDUFA goal date.
  • Baudax holds exclusive global rights to Intravenous (IV) meloxicam, an NDA-pending non-opioid analgesic developed for the treatment of moderate to severe pain.
  • The Companys lead product candidate is a proprietary intravenous (IV) form of meloxicam, a non-opioid, long-acting preferential COX-2 inhibitor.