Your source for the latest industry trends and drug information news.
Volume 7 | Issue 4
February 15, 2025
Contributors:
Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Salome Mawi, PharmD/MBA Candidate and Xintian Wu, PharmD/MBA Candidate
On January 30, 2025, the U.S. Food and Drug Administration (FDA) approved Journavx™ (suzetrigine), a first-in-class non-opioid analgesic, for the treatment of moderate to severe acute pain in adults. Acute pain is sudden onset, short duration discomfort due to tissue injury, trauma, surgery, or other medical conditions. It is often treated with pain relievers that may contain opioids. Journavx™ is a new alternative to opioids that reduces pain by selectively blocking a unique pathway in the nervous system, thereby inhibiting transmission of pain signals from the body to the brain.
The efficacy and safety of Journavx™ was evaluated in two randomized, double-blind, placebo- and active-controlled trials of 874 adult patients with moderate to severe acute pain following surgery. Patients were permitted to use ibuprofen in addition to their treatment medication if they had breakthrough pain. Both trials' results showed a statistically significant superior reduction in pain for those treated with Journavx™ compared to those in the placebo group. Patients treated with Journavx™ achieved a 47% reduction from baseline in their mean Numeric Pain Rating Scale (NPRS) scores while patients in the placebo group had a 31% reduction from baseline. Common adverse reactions include itching, rash, muscle spasms and increased blood level of creatine phosphokinase. Journavx™ cannot be used in patients taking medications that strongly inhibit CYP3A enzymes, including several antibacterial, antifungal, and antiviral medications and patients should also avoid food and drinks containing grapefruit while taking it.
On January 31, 2025, Alvogen, Inc. announced a voluntary recall of one lot of fentanyl 25 mcg/hr transdermal patches. This product is being recalled due to the potential of multiple patches stacked together in a single pouch. Fentanyl transdermal patches are indicated for severe and chronic pain in opioid-tolerant patients. Applying a multi-stacked patch could deliver a dose that is higher than intended, resulting in severe respiratory depression that could be life threatening.
The recalled product was distributed to pharmacies nationwide. It is packaged in cartons containing five individually labeled pouches and is labeled with lot number 108319 and an expiration date of April 2027. Alvogen has provided written notification to distributors and direct customers. Consumers with recalled products should immediately remove any patches they are wearing and contact their health care provider if any problems arise after use. Adverse events should be reported to the FDA's MedWatch Adverse Event Reporting program. To date, Alvogen has received one serious adverse event related to this recall.
On January 30, 2025, Axsome Therapeutics announced that the FDA approved Symbravo® (meloxicam and rizatriptan) for the treatment of acute migraine in adults, with or without aura. Migraine is a neurologic condition that presents as a recurring headache, characterized by throbbing pain that usually occurs on one side of the head and can involve nausea or sensitivity to light or sound. Although migraine affects millions of U.S. adults, many still struggle to find an option that is effective and well-tolerated to manage their headache episodes. Symbravo® is a combination treatment that works by targeting multiple pathways of a migraine attack and can rapidly reduce migraine pain.
The efficacy and safety of Symbravo® have been established in clinical trials. Symbravo® showed a greater percentage of pain relief and relief from the most bothersome symptoms compared to placebo. Reduction of pain at 2 hours after a single dose was sustained through 24 and 48 hours for many patients, and it helped them perform normal daily activities. It was demonstrated that 77% of patients treated with Symbravo® did not require rescue medication within 24 hours. Common adverse effects were drowsiness and dizziness. Symbravo® is expected to be available by the third quarter of 2025.
New Drug: Avtozma® (tocilizumab-anoh)
Intravenous or subcutaneous injection approved as a biosimilar to Actemra® for the treatment of certain inflammatory autoimmune disorders, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis. [1/24/2025 – CELLTRION INC]
Spritam® (levetiracetam)
Indication: For the treatment of partial-onset seizures in patients 4 years and older weighing more than 44 pounds, and as an add-on treatment for myoclonic seizures in patients 12 years and older and for primary generalized tonic-clonic seizures in patients 6 years and older.
Dosage Form/Strength: 250mg tablets for oral suspension
Average Wholesale Price (AWP): Generic = $2,700 | Brand = $1,550
