European Pharmaceutical Agent (EMA) has concluded a review of weight loss drugs Naltrexon/Bupropion (MySimba), prompted by concerns about potential long-term cardiovascular risks. The Scientific Assessment of the EMA’s Drug Committee for Human Use (CHMP) (CHMP) suggests that the available data suggest that the benefits of its approved indication “continue to outweigh its risks.” However, the cardiovascular safety of the drug in patients treated for more than 12 months has not been fully determined and “before uncertain,” drug regulators said.
Naltrexone/bupropion was given marketing approval in 2015 as a drug used along with diet and exercise to manage adult weight. obesitydefined as a BMI of 30 kg/m2 People with more than that, or overweight (BMI between 27 and 30) and weight-related comorbidities ( Type 2 diabetesdyslipidemia, or control Hypertension.
Each tablet contains 8 mg of naltrexone hydrochloride, equivalent to 7.2 mg of naltrexone, and 90 mg of hydrochloride hydrochloride, equivalent to 78 mg of bupropion. If the patient has not lost at least 5% of his initial weight, treatment must be discontinued after 16 weeks, and then the need for continuous treatment should be reassessed annually.
Long-term cardiovascular risk
At the time of approval, CHMPs noted uncertainty regarding the long-term effects of naltrexone/bupropion on the cardiovascular system. Previous studies have not shown cardiovascular safety concerns when the drug is used for up to 12 months. However, the available data is not sufficient to fully determine cardiovascular safety beyond this time.
The drug has been influenced by several reviews and marketing approval variations due to concerns about various side effects and interactions with other opioid-containing drugs.
The current review was launched in September 2023 at the request of the European Commission (EC) under Article 20 of the EC regulations. This causes the procedure of the drug permitted via a centralized procedure in the case of quality, safety, or efficacy issues. CHMP highlighted remaining concerns about the potential long-term Cardiovascular risk. Following a review of available data, the opinion concludes that the benefits of naltrexone/bupropion in approved indications continue to outweigh its risks. However, the cardiovascular safety of concomitant medications in patients treated for more than 12 months has not been fully determined and remains uncertain.
During the review, CHMP reviewed all available data in relation to cardiovascular safety of naltrexone/bupropion, including data from clinical studies and clinical practice, spontaneous reports of side effects and data from the literature. Clinical and literature data on drug efficacy were also considered.
Trials to be reported in 2028
The EMA said that ongoing practical, randomized, placebo-controlled studies (information) for future future futures have been proposed by the manufacturer to assess the long-term cardiovascular safety of naltrexone/bupropion within 12 months. CHMP said the trial is appropriate to generate evidence of this risk in the long term and results are expected in 2028. The assessment is a condition for ongoing marketing approval and the company must provide an annual report on the progress of the investigation.
On the other hand, medical professionals advised that treatment with naltrexone/bupropion should be discontinued if there is concern about the safety or tolerability of continuous treatment and concern about the perseverance of continuous treatment. Increased blood pressure. Patients should be reviewed annually, and physicians should discuss whether the combination remains beneficial to them, taking into account whether changes in the patient’s cardiovascular risk and weight loss are maintained.
Existing recommendations have been clarified and strengthened to minimize potential cardiovascular risks from long-term use of the drug, the EMA said. Product information and checklists from healthcare professionals have been updated to reflect the results of this review. A letter containing these recommendations will be sent over time to the healthcare professional who prescribes, dispenses, or administers the medication.
CHMP’s opinions will be transferred to the EC, which will issue a final, legally binding decision that applies to all EU Member States.
Dr. Sheena Meredith is an established medical writer, editor and consultant at Medical Communications, and has extensive writing for medical professionals and the public. She is qualified in medicine, law and medical ethics.
