FDA Approves Nalmefene Auto-Injector to Reverse Opioid Overdose

On August 7, 2024, the U.S. Food and Drug Administration (FDA) approved Purdue Pharma’s Zurnai^® (nalmefene) autoinjector for emergency treatment of opioid overdose in individuals aged 12 years and older. Nalmefene, an opioid receptor antagonist, reverses overdose effects like respiratory depression, sedation, and hypotension. The recommended dose is 1.5mg administered subcutaneously (SC) or intramuscularly (IM), followed by immediate contact with emergency services. Additional doses may be given every two to five minutes until help arrives. Opioid overdose, including synthetic opioids like fentanyl, continues to be a significant public health issue, with over 107,000 deaths in 2023. Nalmefene is noted for its rapid onset and longer duration of action compared to naloxone, especially against synthetic opioids. Single-dose vials of nalmefene for injection re-entered the market in 2022. Additionally, Opvee^® (nalmefene – Opiant Pharmaceuticals) nasal spray was approved in 2023. Another drug used to treat opioid overdose is naloxone, which is available in nasal and injectable formulations. Some nasal formulations of naloxone are also available for over-the-counter (OTC) sales. Zurnai will be available by prescription, but pricing and availability details are pending. It was granted fast track and priority review designations to expedite the approval process. Look here for current prescribing information.

Crexont Approved for Parkinson’s Disease

The FDA approved Amneal Pharmaceuticals’ Crexont^® (carbidopa and levodopa) extended-release capsules on August 8, 2024, for treating Parkinson’s disease (PD). It is also indicated for treating Parkinsonism after brain infections (post-encephalitis), carbon monoxide poisoning, or manganese toxicity. Parkinsonism includes Parkinson’s disease and a range of similar neurological disorders that are caused by dopamine imbalances in the brain. Crexont contains both immediate-release and extended-release forms of both medications. Depending on the patient’s response and the amount of drug needed to control symptoms, doses can be administered two to three times daily. The maximum recommended daily dosage of Crexont is 525mg carbidopa/2,100mg levodopa. As with other carbidopa-levodopa drugs, labeling for Crexont warns that taking it may be associated with intense urges to gamble, binge eat, or engage in other kinds of impulsive behaviors. Additionally, levodopa can cause sudden extreme drowsiness.  Approximately one million adults in the U.S. are living with PD. Crexont extended-release capsules are expected to launch in September 2024 in four fixed-dose strengths (carbidopa/levodopa): 35mg/140mg, 52.5mg/210mg, 70mg/280mg, and 87.5mg/350mg capsules. Once available, it will compete with other immediate-release and long-acting formulations of the same drugs. Here is its prescribing information.

Fibryga Now Approved to Treat Acquired Fibrinogen Deficiency

Octapharma’s Fibryga^® (fibrinogen [human]) lyophilized powder for reconstitution received a new indication on Aug. 7, 2024, to treat acquired fibrinogen deficiency. This form of fibrinogen deficiency is generally the result of excessive blood loss and clotting caused by a trauma or major surgery that uses up the body’s reserve of fibrinogen in the blood. Fibryga was first FDA-approved in 2017 to treat adolescents and adults with congenital fibrinogen deficiency. This indication was later expanded to include children of all ages with this condition. The intravenous (IV) dose can vary depending on several factors, including age, weight, and plasma fibrinogen levels. Its revised prescribing information may be found here.

Jemperli’s Endometrial Cancer Indication Expanded

On August 1, 2024, GSK announced that the FDA expanded the indication for Jemperli^® (dostarlimab-gxly) in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent, for treating adult patients with primary advanced or recurrent endometrial cancer. This approval now includes patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) tumors, which represent the majority of endometrial cancer cases. The approval was based on an interim analysis from a Phase III trial, which showed a 72% reduction in disease progression or death risk in this population. Jemperli is an antibody that works by binding to the PD-1 receptor, blocking its interaction with PD-L1 and PD-L2. This results in the activation of T-cells to attack the cancer cells. Given as 30-minute-long IV infusions, the recommended dosing for Jemperli for this use is 500mg once every three weeks, together with chemo, for six cycles. Then, Jemperli is used alone at 1,000mg once every six weeks. Jemperli was previously approved for treating dMMR recurrent or advanced endometrial cancer and dMMR solid tumors that have no other treatment options. The expanded indication received a priority review and received approval ahead of its August 28, 2024, action date. Here is its updated prescribing information.

Fabhalta Approved for Immunoglobulin A Nephropathy

On Aug. 7, 2024, Novartis received accelerated approval for Fabhalta^® (iptacopan) to reduce protein in the urine (proteinuria) in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. This is usually characterized as a urine protein-to-creatinine ratio (UPCR) ≥1.5g/g. IgAN is an autoimmune kidney disease that affects approximately 100,000 Americans. It slowly causes kidney damage and up to 50% of patients will develop kidney failure within 20 years of diagnosis. Accelerated approval of Fabhalta was based on interim results from an ongoing Phase III study that showed that at nine months, patients in the treatment group achieved a 38% reduction in proteinuria compared to those randomized to placebo. Final study results to determine if Fabhalta slows kidney function decline, as measured by estimated glomerular filtration rate (eGFR) decline over 24 months, is required before the FDA will consider granting full approval for this expanded indication. Complete data from this study are expected to be available next year. Fabhalta was originally approved in Dec. 2023 to treat adults with paroxysmal nocturnal hemoglobinuria (PNH). It is a complement factor B inhibitor and the recommended dose for both indications is 200mg twice daily. Fabhalta has a boxed warning and a risk evaluation and mitigation strategy (REMS) due to the risk of severe infections that may be associated with its use. Updated prescribing information can be found here.

Upsher-Smith Launches Torpenz for Tuberous Sclerosis Complex

On August 5, 2024, Upsher-Smith announced the launch of Torpenz^™ (everolimus) tablets for treating patients with tuberous sclerosis complex (TSC). It is a brand name assigned to Biocon Pharma’s A-rated generic to Afinitor^® (everolimus – Novartis) tablets. Upsher-Smith is combining access to this product with the company’s Promise of Support^™ program to help provide support to patients, caregivers, and healthcare providers during the patient’s treatment. Everolimus works by inhibiting the mTOR pathway, which is involved in cell growth and proliferation. The recommended dosing for these indications is based on the patient’s body surface area and specific condition. Torpenz is available exclusively through the specialty pharmacy PantherRx^® Rare as 2.5mg, 5mg, 7.5mg, and 10mg Tablets. More about this program and the drug’s full prescribing information can be found on the company’s website, which can be found here.

Recall

Gabapentin Recalled

On July 31, 2024, Granules Pharmaceuticals Inc. recalled one lot of gabapentin 600mg tablets. The recall was initiated due to an error resulting in metformin extended-release tablets found in a bottle of gabapentin 600mg tablets. Gabapentin is commonly used as an anticonvulsant to manage specific types of epilepsy and to alleviate nerve pain associated with various conditions. Metformin helps control blood sugar and is utilized to regulate blood sugar levels and treat type 2 diabetes mellitus (T2DM). Patients who accidentally take metformin instead of their gabapentin could potentially be at risk for seizures or nerve pain depending on the condition being treated. Additionally, patients could suffer adverse effects from the unwanted metformin including nausea, vomiting, diarrhea, upset stomach, or metallic taste. Metformin doesn’t usually cause low blood pressure on its own, but there is a potential risk if combined with other medications to treat diabetes or high blood sugar. For more information, please contact the manufacturer at 877.770.3183 or you can email drugs.safety@granulesindia.com.