Opioid-sparing Effects of SoluMatrix Indomethacin in a Phase 3 Study in Patients With Acute Postoperative Pain.

Objectives: To report the opioid-sparing effects of SoluMatrix indomethacin, developed using SoluMatrix Fine Particle Technology, in a phase 3 study in patients with acute pain following bunionectomy.

Methods: This phase 3, placebo-controlled study randomized 462 patients with moderate-to-severe pain following bunionectomy surgery to receive SoluMatrix indomethacin 40 mg 3 times daily, SoluMatrix indomethacin 40 mg twice daily, SoluMatrix indomethacin 20 mg 3 times daily, celecoxib 400-mg loading dose followed by 200 mg twice daily, or placebo. Patients were permitted to receive opioid-containing rescue medication throughout the study.

Low-dose SoluMatrix diclofenac in patients with osteoarthritis pain: impact on quality of life in a controlled trial.

Low-dose SoluMatrix diclofenac was developed to provide effective pain relief for osteoarthritis pain. We evaluated the effects of SoluMatrix diclofenac on health-related quality of life (HRQoL) measures in patients with osteoarthritis, hypothesizing that SoluMatrix-treated patients would experience significant improvement compared with placebo. In this 12-week, phase 3 randomized controlled trial, 305 patients with osteoarthritis of the hip or knee received SoluMatrix diclofenac 35 mg three times (TID) or twice (BID) daily or placebo.

SoluMatrix® Diclofenac: Sustained Opioid-Sparing Effects in a Phase 3 Study in Patients with Postoperative Pain.

Objectives: To evaluate opioid rescue medication usage and the opioid-sparing effect of low-dose SoluMatrix diclofenac developed using SoluMatrix Fine Particle Technology™ in a phase 3 study in patients experiencing pain following bunionectomy surgery.

Design: Multicenter, randomized, double-blind, parallel-group study (NCT01462435).

Setting: Four clinical research centers in the United States.

Pharmacokinetic properties of low-dose SoluMatrix meloxicam in healthy adults.

SoluMatrix® meloxicam has been developed using SoluMatrix Fine Particle Technology™ to produce a meloxicam drug product with enhanced absorption properties to enable treatment at lower doses than available oral meloxicam drug products. This follows recognition of serious dose-dependent adverse events (AEs) associated with nonsteroidal anti-inflammatory drugs, including meloxicam. This study investigated the pharmacokinetic (PK) properties of SoluMatrix meloxicam 5-mg (fasting conditions) and 10-mg capsules (fasting and fed conditions) and compared SoluMatrix meloxicam 10-mg capsules with meloxicam 15-mg tablets under fasting conditions.

Efficacy and safety of low-dose SoluMatrix meloxicam in the treatment of osteoarthritis pain: a 12-week, phase 3 study.

Objective: Nonsteroidal anti-inflammatory drugs (NSAIDs) such as meloxicam are commonly used to treat osteoarthritis (OA) but are associated with potentially serious dose-related adverse events (AEs). SoluMatrix meloxicam has been developed with the goal of enabling effective treatment at low doses. This phase 3 study evaluated the efficacy and safety of low-dose SoluMatrix meloxicam capsules 5 mg and 10 mg administered once daily for 12 weeks in patients with OA-related pain.

Low-dose SoluMatrix diclofenac : a review of safety across two Phase III studies in patients with acute and osteoarthritis pain.

Introduction: Similar to other NSAIDs, diclofenac is associated with serious dose-related cardiovascular, gastrointestinal, and renal adverse events. Low-dose SoluMatrix diclofenac , containing submicron particles of diclofenac, was developed to provide effective analgesia at lower drug doses compared with currently available NSAIDs.

Areas Covered: The efficacy and safety of low-dose SoluMatrix diclofenac was evaluated in two randomized, placebo-controlled Phase III studies: a study in patients with acute pain following bunionectomy surgery and a study in patients with osteoarthritis pain of the hip or knee.

Advances in NSAID development: evolution of diclofenac products using pharmaceutical technology.

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) of the phenylacetic acid class with anti-inflammatory, analgesic, and antipyretic properties. Contrary to the action of many traditional NSAIDs, diclofenac inhibits cyclooxygenase (COX)-2 enzyme with greater potency than it does COX-1. Similar to other NSAIDs, diclofenac is associated with serious dose-dependent gastrointestinal, cardiovascular, and renal adverse effects.

Low-dose SoluMatrix diclofenac in the treatment of osteoarthritis: A 1-year, open-label, Phase III safety study.

Introduction: Diclofenac is used for the treatment of osteoarthritis (OA); however, like other nonsteroidal anti-inflammatory drugs (NSAIDs) it can be associated with serious dose-related adverse events (AEs). Low-dose SoluMatrix® diclofenac has been developed to provide efficacy at lower diclofenac doses. A recently published Phase III study evaluated the efficacy and safety of SoluMatrix diclofenac 35 mg twice daily (b.

Pharmacokinetics and safety of low-dose submicron indomethacin 20 and 40 mg compared with indomethacin 50 mg.

Introduction: Indomethacin is a potent analgesic that, similar to other nonsteroidal anti-inflammatory drugs, is associated with serious dose-related adverse events. There is a need for newer nonsteroidal anti-inflammatory drug products with improved tolerability. Low-dose submicron indomethacin was developed using SoluMatrix Fine Particle Technology™ to enable treatment at lower doses than commercially available indomethacin drug products.

Pharmacokinetic properties and tolerability of low-dose SoluMatrix diclofenac.

Purpose: This study compared the pharmacokinetic properties and safety profile of low-dose (18- and 35-mg) diclofenac capsules manufactured using SoluMatrix Fine Particle Technology (Trademark of iCeutica Inc. (Philadelphia, Pennsylvania), and the technology is licensed to Iroko Pharmaceuticals, LLC (Philadelphia, Pennsylvania) for exclusive use in NSAIDs), which produces submicron-sized drug particles with enhanced dissolution properties, to those of diclofenac potassium immediate-release (IR) 50-mg tablets.

Methods: This Phase 1, single-center, randomized, open-label, single-dose crossover study was conducted in 40 healthy volunteers.

Efficacy and safety of low-dose submicron diclofenac for the treatment of osteoarthritis pain: a 12 week, phase 3 study.

Objective: NSAIDs, such as diclofenac, are the most commonly used medications to treat osteoarthritis (OA), but they are associated with dose-related adverse events (AEs). Low-dose submicron diclofenac was developed using a new, proprietary dry milling process that creates submicron drug particles (SoluMatrix Fine Particle Technology * ), enabling effective treatment at lower doses than other commercially available diclofenac drug products. This phase 3 study evaluated the efficacy and safety of low-dose submicron diclofenac 35 mg three times daily (tid) and twice daily (bid) in patients with OA pain.

A phase 2 study of lower-dose, indomethacin submicron particle capsules demonstrates early onset of acute pain relief.

Objectives: Nonsteroidal anti-inflammatory drugs are efficacious for the treatment of acute and chronic pain; however, they have the potential for serious adverse events (AEs). The objective of this study was to evaluate the efficacy and safety of investigational, lower-dose, indomethacin submicron particle capsules compared with placebo in a study of patients with postsurgical pain.

Materials And Methods: This phase 2, multicenter, randomized, double-blind, single-dose, and placebo-controlled study enrolled 203 patients (18 to 50 y old) following extraction of ≥ 2 third molars who experienced moderate-to-severe pain intensity ≤ 6 hours after surgery.

Indomethacin submicron particle capsules provide effective pain relief in patients with acute pain: a phase 3 study.

Although frequently prescribed to relieve acute pain in patients, non-steroidal anti-inflammatory drugs (NSAIDs) are associated with dose-related gastrointestinal, cardiovascular, and renal complications. Investigational, submicron particle NSAIDs are being developed that could provide effective pain relief at lower doses than currently available oral NSAIDs. This is the first phase 3 study evaluating the analgesic efficacy and safety of lower-dose indomethacin submicron particle capsules in patients following elective surgery.

A phase 2 study of naproxen submicron particle capsules in patients with post-surgical dental pain.

Background: Naproxen is an NSAID with documented efficacy in pain management; however, it is associated with serious dose-related adverse events. A lower-dose naproxen drug product with comparable efficacy to commercially available naproxen could address these concerns. We studied the efficacy and safety of naproxen submicron particle capsules in patients with acute post-surgical dental pain.

Lower-dose diclofenac submicron particle capsules provide early and sustained acute patient pain relief in a phase 3 study.

Background: Non-steroidal anti-inflammatory drugs are prescribed for the treatment of patients with acute pain but use of such analgesics is associated with dose-dependent adverse events (AEs). Diclofenac submicron particle capsules have been developed using SoluMatrix technology to provide analgesia at lower doses than available solid oral dosing forms. Our study evaluated the analgesic efficacy and safety of lower-dose diclofenac submicron particle capsules in patients with acute pain following elective surgery.

Oral famciclovir for the suppression of recurrent genital herpes: the combined data from two randomized controlled trials.

Background: Genital herpes is a very common sexually transmitted disease. Safe and effective therapies are needed for patients with frequent recurrences.

Objective: The aim of our study was to determine the efficacy and safety of famciclovir for suppression of herpes simplex virus (HSV) infection in patients with history of clinically diagnosed recurrent genital HSV infection.