PDR Drug Update - March 2025

Advancement of Nonopioid Pain Management

Opioids have been the cornerstone for treating acute and chronic pain, but their addictive potential and adverse effects continue to be liabilities. Studies indicate that approximately 75% of postoperative patients experience moderate-to-severe pain. Alarmingly, about 10% of those patients initially prescribed opioids for acute pain develop long-term use patterns, with tens of thousands progressing to opioid use disorder annually. Given these statistics, the need for safer, effective alternatives for pain management is critical.

In response to the public health crisis of opioid use disorder, characterized by misuse, dependence, and overdose, regulatory agencies and researchers have advocated for opioid-sparing strategies and the development of novel treatments that target pain-specific pathways without affecting other critical physiological functions. Pain perception begins with specialized sensory nerve cells that detect harmful stimuli, such as mechanical injury, exposure to extreme temperatures, or environmental irritants. These cells transmit pain signals from peripheral tissues to the spinal cord and brain via a network of voltage-gated sodium (NaV) channels that are embedded in their membranes. When activated, these channels allow sodium ion channels to carry the generated electrical impulses to where pain is perceived in the brain.

Multiple NaV channels have been identified, with NaV1.7, NaV1.8, and NaV1.9 noted as crucial mediators of pain signaling. NaV1.7 is responsible for initiating pain signals, while NaV1.8 amplifies and sustains them, playing a dominant role in pain transmission. Unlike NaV1.7, which is also found in non-pain-related pathways, NaV1.8 is selectively expressed in peripheral nociceptive neurons, making it an ideal therapeutic target for pain relief. Recent advances in researching this promising target for nonopioid pain relief have led to the development and FDA approval of a therapy in a new nonopioid analgesic class for the first time in over two decades. Journavx (suzetrigine) is the first FDA-approved NaV1.8 inhibitor designed to selectively block pain transmission at its source without affecting other vital sodium channels involved in cardiac or neurological functions. By inhibiting NaV1.8, suzetrigine prevents the propagation of pain signals while preserving normal sensory and motor functions.

In clinical trials, suzetrigine demonstrated significant pain relief in patients undergoing abdominoplasty and bunionectomy surgeries. Patients who received suzetrigine reported a reduction in pain scores comparable to those treated with hydrocodone-acetaminophen, a common opioid analgesic. Moreover, suzetrigine exhibited a rapid onset of action and a favorable safety profile, with most adverse events classified as mild to moderate. Unlike opioids, which alter pain perception in the brain and activate reward pathways that can lead to addiction, suzetrigine works peripherally, directly blocking pain signals before reaching the central nervous system. This eliminates the risks of euphoria, respiratory depression, and dependence, addressing a critical limitation of opioid therapy.

By providing effective pain relief without addictive potential, suzetrigine aligns with the broader goal of implementing multimodal pain management strategies that incorporate nonopioid analgesics, NSAIDs, acetaminophen, and interventional therapies. The approval of suzetrigine represents a significant advancement in pain management toward precision-targeted, peripheral-acting therapies. Early-phase studies have shown promise for suzetrigine in treating chronic pain conditions, such as painful diabetic peripheral neuropathy and lumbosacral radiculopathy. However, much additional research is needed to explore its long-term safety and potential applications beyond acute pain.

While further studies are necessary, its introduction into clinical practice represents a significant step toward reducing opioid reliance and improving patient outcomes. The future of pain management is continuing to grow to include more targeted and effective nonopioid treatments. Stay informed about advances in treating acute and chronic pain by exploring PDR by ConnectiveRx. You can also stay current by using the official PDR app, mobilePDR, which is available for free from your preferred app store.

FDA New Approvals

Avtozma

The FDA has approved Avtozma (tocilizumab-anoh) in both an intravenous and subcutaneous formulation as a biosimilar to Actemra. Avtozma is indicated for the treatment of multiple diseases including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19. Learn more about Avtozma

Ctexli

The FDA has approved Ctexli (chenodiol) tablets, a bile acid, for the treatment of adults with cerebrotendinous xanthomatosis. Learn more about Ctexli

Emblaveo

The FDA has approved Emblaveo (aztreonam and avibactam) as the first and only fixed-dose, intravenous, monobactam/β-lactamase inhibitor combination antibiotic. It is approved in combination with metronidazole for patients aged 18 years and older who have limited or no alternative options for the treatment of complicated intra-abdominal infections, including those caused by Gram-negative bacteria. Learn more about Emblaveo

Gomekli

The FDA has approved Gomekli (mirdametinib), a MEK inhibitor, for the treatment of adult and pediatric patients aged 2 years and older with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection. Learn more about Gomekli

Grafapex

The FDA has approved Grafapex (treosulfan), an alkylating agent, with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients aged 1 year and older with acute myeloid leukemia or myelodysplastic syndrome. Learn more about Grafapex

Merilog

The FDA has approved Merilog (insulin-aspart-szjj) as biosimilar to Novolog (insulin aspart) for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus. Learn more about Merilog

Miudella

The FDA has approved Miudella (copper intrauterine system) for the prevention of pregnancy in females of reproductive potential for up to three years. Learn more about Miudella

Onapgo

The FDA has approved Onapgo (apomorphine hydrochloride) injection as the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinson’s disease. Learn more about Onapgo

Ospomyv

The FDA has approved Ospomyv (denosumab-dssb) for the treatment of postmenopausal women with osteoporosis at high risk for fracture, treatment to increase bone mass in men with osteoporosis at high risk for fracture, treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture, treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and for the treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. Learn more about Ospomyv

Penmenvy

The FDA has approved Penmenvy (meningococcal Groups A, B, C, W, and Y vaccine) for use in individuals aged 10 through 25 years. The vaccine targets five major serogroups of Neisseria meningitidis (A, B, C, W, and Y), which commonly cause invasive meningococcal disease. Learn more about Penmenvy

Romvimza

The FDA has approved Romvimza (vimseltinib), a kinase inhibitor, for adult patients with symptomatic tenosynovial giant cell tumor for which surgical resection will potentially cause worsening functional limitation or severe morbidity. Learn more about Romvimza

Stoboclo

The FDA has approved Stoboclo (denosumab-bmwo) for treatment: of postmenopausal women with osteoporosis at high risk for fracture; to increase bone mass in men with osteoporosis at high risk for fracture; of glucocorticoid-induced osteoporosis in men and women at high risk for fracture; to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer; and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. Learn more about Stoboclo

Vimkunya

The FDA has approved Vimkunya (chikungunya vaccine, recombinant) for injection, the first virus-like particle single-dose chikungunya vaccine in the US for persons aged 12 years and older. Learn more about Vimkunya

Xbryk

The FDA has approved Xbryk (denosumab-dssb) for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. Learn more about Xbryk

FDA Labeling Changes

Evrysdi

The FDA has approved an Evrysdi (risdiplam) tablet for people living with spinal muscular atrophy. The Evrysdi oral solution will remain available for those on other doses of Evrysdi and for those who may prefer the oral solution. Learn more about Evrysdi

Sublocade

The FDA has approved label changes for Sublocade (buprenorphine extended-release) injection, including a rapid initiation protocol and alternative injection sites, marking a significant advancement in the treatment of moderate-to-severe opioid use disorder. Learn more about Sublocade

FDA New Indications

Adcetris

The FDA has approved Adcetris (brentuximab vedotin) in combination with lenalidomide and a rituximab product for the treatment of adult patients with relapsed or refractory large B-cell lymphoma. This represents the eighth FDA-approved indication for Adcetris. Learn more about Adcetris

Odactra

The FDA has approved Odactra house dust mite (Dermatophagoides farinae and Dermatophagoides pteronyssinus) allergen extract sublingual tablets for the treatment of patients aged 12 through 65 years with house dust mite-induced allergic rhinitis, with or without conjunctivitis, to now include children aged 5 through 11 years. Learn more about Odactra

Susvimo

The FDA has approved Susvimo (ranibizumab injection) 100mg/mL for the treatment of diabetic macular edema. The approval marks the second indication for Susvimo in addition to neovascular or ‘wet’ age-related macular degeneration. Learn more about Susvimo

FDA Recalls

Ascent Consumer Products SinuCleanse

Ascent Consumer Products Inc. is voluntarily recalling one lot of SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System to the consumer level. The recall is being initiated due to a confirmed test result of microbial contamination of the product with Staphylococcus aureus. Learn more about the SinuCleanse recall

BD ChloraPrep

BD announced the voluntary recall of one lot of ChloraPrep Clear 1mL applicators due to fungal contamination under certain environmental conditions allowing the growth of Aspergillus penicillioides. Learn more about the ChloraPrep recall

Central Admixture Pharmacy Services Phenylephrine

Central Admixture Pharmacy is recalling three lots of phenylephrine 40mg added to 0.9% sodium chloride 250mL in 250mL Excel bags (NDC: 71285-6092-1) to the hospital level. The product is being recalled because of the detection of visible black particulate matter in a single sealed vial of phenylephrine hydrochloride. Learn more about the phenylephrine recall

ICU Medical Potassium Chloride

ICU Medical, Inc. is voluntarily recalling one lot each of potassium chloride injection bags with overwrap labels 10mEq, packaged in cases of potassium chloride injection 20mEq, to the user level. ICU Medical has received a customer complaint stating that bags of potassium chloride injection 20mEq have incorrect overwrap labels stating potassium chloride injection 10mEq. Learn more about the potassium chloride recall

Natural Dior Vitafer-L Gold

Natural Dior LLC is voluntarily recalling the affected lots of Vitafer-L Gold Liquid, a dietary supplement with iron and vitamins, to the consumer level. The product has been found to contain undeclared tadalafil. Learn more about the Vitafer-L Gold recall

One Source Nutrition Vitality

One Source Nutrition is voluntarily recalling all lots of Vitality capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil and tadalafil. Learn more about the Vitality recall

March 2025