2020-02-23| Trials & Approvals

Relief for Patients as Baudax Bio’s Non-Opioid Analgesic Wins FDA Approval

by Ruchi Jhonsa
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By Ruchi Jhonsa, Ph.D.

Pain is an unpleasant feeling that is associated with actual or potential tissue damage. Physiologically, the function of pain is important for survival and has an evolutionary advantage. However, if it persists for long, pain can hamper a person’s normal day-to-day activities. Depending upon the intensity or severity and area of origin, pain can be classified into different categories. Although different medications are available for treatment, only three major pain relievers- acetaminophen, non- steroidal anti-inflammatory drugs (NSAIDs) and opioids are used frequently. However, each of these drugs has its limitations. Acetaminophen is the least harmful but the least potent as well. On the other hand, NSAIDs and opioids are the most effective but also causes several adverse effects.

In an effort to develop a potent pain reliever with minimal side effects, Baudax Bio announced FDA approval for ANJESO (meloxicam), an NSAID pain reliever for moderate to severe pain. ANJESO is so far the only available 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) that offers once-daily dosing. However, it is a delayed onset analgesic and is therefore not recommended for use when a rapid onset of analgesia is required. The company believes that this non-opioid drug will discourage the opioid crisis currently affecting the country and will simultaneously reduce opioid-related health issues. ANJESO is expected to be launched in April or May this year.

Sharing his excitement at the positive news, Gerri Henwood, President, and CEO of Baudax Bio said, “The approval of ANJESO marks a major advancement in the treatment landscape for managing moderate to severe pain. With our nation currently in the midst of a national opioid epidemic, we are thrilled to be able to offer a novel, non-opioid therapeutic option with the potential to meaningfully impact the acute pain treatment paradigm. We expect to make ANJESO available to physicians and patients in late April or early May 2020.”


Successful Phase III Trials

ANJESO is a non-steroidal anti-inflammatory drug that can reduce pain, inflammation and body temperature at once. It preferentially mediates these actions by acting on the cyclooxygenase type 2 pathway to reduce the synthesis of prostaglandin, a chemical molecule that relays pain signals to the neurons. ANJESO was designed using the NanoCrystal platform, a technology that helps overcome the solubility difficulty of many water-insoluble drugs.

The FDA approval for ANJESO was supported by data from two Phase III efficacy studies, one double blind, placebo-controlled Phase III safety study and four Phase II clinical studies. The two Phase III studies evaluated ANJESO’s efficacy following Bunionectomy and Abdominoplasty surgery.


Drug Efficacy Post Surgery

Abdominoplasty Surgery

In the multicenter, randomized, double blind, placebo-controlled clinical trial participants were randomly assigned to receive a postoperative regimen of ANJESO (30mg) or placebo once every 24 hours following surgery. The drug arm demonstrated a statistically significant reduction in SPID24, a cumulative pain intensity score measured over 24 hours, compared to placebo. Moreover, 10 of the secondary endpoints that included SPID12, time to perceptible pain relief and some other pain metrics were also met.

Bunionectomy Surgery

Similar to Abdominoplasty surgery, participants were randomly assigned to receive 30mg ANJESO or placebo after Bunionectomy surgery for once every 24 hours for up to 3 doses. The drug arm met the primary endpoint by statistically reducing SPID48 compared to the placebo arm. Additionally, ANJESO was able to significantly improve other secondary endpoints like SPID6, SPID12, SPID24, and other pain relief metrics during the first 48hours.


Safety Results Following Major Surgery

Patients, who had undergone major surgical procedures like total hip and knee surgery, spinal, GI, hernia repair and other range of surgeries, were either given ANJESO or placebo daily for up to 7 doses. However, since ANJESO is delayed onset analgesic, it was given along with opioids or other pain management modes. The total occurrence of patients with at least one adverse event was lower for the ANJESO group (2.6%) than in the placebo group (5.5%). The most common adverse reactions reported n >2% patients treated with the drug and at a greater frequency than placebo included: constipation, gamma-glutamyl transferase increased and anemia. Overall, ANJESO was determined to be safer for use after surgery.

“The safety and efficacy of ANJESO have been well established through several mid-and late-stage clinical studies,” said Stewart McCallum, M.D., Chief Medical Officer of Baudax Bio. “Moreover, data from our Phase III safety trial demonstrated that ANJESO is well tolerated and impacted opioid consumption compared to placebo, further highlighting its value to patients, providers, and health systems.”

Related Article: Trevena Inc. Gives Oliceridine Approval Another Shot



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