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New NDA for Non-Opioid Pain Medication

August 2, 2017
IV meloxicam, from Recro Pharma, Inc, has been submitted for consideration for approval to the US Food and Drug Administration. The product uses a microtechnology to reduce toxicity of NSAIDs.

Recro Pharma has submitted a New Drug Application (NDA) for IV meloxicam (30 mg), which contains microcrystal technology, based on positive results from clinical trials showing significant pain reduction and opioid-sparing after surgery, according to a press release from the company.1 Recro told Practical Pain Management that it has not yet announced a brandname for their nonsteroidal anti-inflammatory drug (NSAID).

The studies submitted to the US Food and Drug Administration (FDA) included a Phase III trial in patients following bunionectomy and abdominoplasty surgeries, a large double-blind Phase III safety trial, and 4 Phase II clinical trials for the management of moderate to severe postoperative pain, among others.

In the first Phase III efficacy trial, IV meloxicam 30 mg "achieved the primary endpoint of a statistically significant difference in Summed Pain Intensity Difference (SPID) over the first 48 hours (SPID48) compared to placebo in patients following bunionectomy surgery," according to a release from Recro Pharma. In the second Phase III efficacy trial, IV meloxicam 30 mg produced a statistically significant difference in SPID over the first 24 hours (SPID24) compared to placebo in patients following abdominoplasty surgery, reported the company.

Bunionectomy is one of the most painful surgical conditions. In clinical trials, IV meloxicam 30 mg was found to significant reduce pain compared to placebo.

Bunionectomy, one of the most painful procedures, is an ideal operation to study the agents efficacy in a hard tissue model, while abdominal surgery is an ideal representation of a soft tissue model, noted the company. In the large safety trial, the agent was shown to be well tolerated and demonstrated a solid safety and tolerability profile.

Meloxicam is a long-acting, preferential cyclooxygenase-2 (COX-2) inhibitor that has analgesic, anti-inflammatory, and antipyretic activities. Because oral meloxicam has a slow onset of action, largely due to poor solubility, the new agent uses "NanoCrystal technology, which has been shown to provide a rapid onset of action of meloxicam," noted the company in a email interview. NanoCrystal is a registered trademark of Alkermes Pharma Ireland Limited (APIL).

The hope is that a more powerful, yet safer, NSAID will help reduce the need for postoperative opioids to manage pain. According to the company, IV meloxicam 30 mg did reduce the overall use of opioids. In a Phase III clinical trial, patients who had undergone major surgeries, including total hip and knee replacements, spinal, GI, hernia repair, and gynecologic surgeries, were randomized in a 3:1 ratio to receive either IV meloxicam 30 mg or IV placebo daily for up to 7 doses. Study centers were permitted to use opioids and other pain management modes according to their “standard of care” and meloxicam or placebo was added to this regimen. A total of 721 patients received at least 1 dose of study medication.

According to the results, "overall opioid use was lower, and 'time to first use' of opioids was significantly longer, in the IV meloxicam 30mg treatment arm, compared to placebo," noted the company.2

In October 2015, the FDA approved Iroko's  Vivlodex (meloxicam, 5 mg and 10 mg doses administered once daily) capsules for the management of osteoarthritis pain. Vivlodex was developed using SoluMatrix Fine Particle Technology, which contains submicron particles of meloxicam that are approximately 10 times smaller than their original size.

The use of the nanotechnology allows "the reduction in particle size provides an increased surface area, leading to faster dissolution.This allows clinicians to prescribe the lowest effective dose of NSAIDs for the shortest possible duration and marks an important milestone for the 27 million Americans who live with osteoarthritis,” noted Oroko.

The development of microparticle meloxicam products is in align with FDA  safety recommendations. In July 2015, the FDA strengthened the existing warning labels for non-aspirin NSAIDs.4 The serious cardiovascular and gastrointestinal adverse events associated with NSAIDs are dose-related and risk may occur early in treatment and may increase with duration of use.

 

Last updated on: August 2, 2017
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FDA Approves Vivlodex (meloxicam)
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