Acromegaly patients now have new hope after FDA recently approved Palsonify to treat adults who weren’t able to undergo surgery or had limited response to surgery, giving them hope with better outcomes.
Acromegaly is a rare endocrine disorder in which the pituitary gland produces excessive growth hormone (GH), usually because of a non-cancerous tumor. This leads to abnormal growth of bones, organs, and other body tissues.
Palsonify’s safety and efficacy were evaluated in two phase 3 randomized, double-blind, placebo-controlled trials involving adults with acromegaly. In the first study, 56% of patients treated with Palsonify achieved normal growth hormone (GH) and insulin-like growth factor (IGF-1) levels at 24 weeks, compared to 5% on placebo. In the second study, 83% of patients who had previously responded to other therapies maintained biochemical control at 36 weeks with Palsonify, versus 4% with placebo.
As for the dosing, the recommended initial dose is 40 mg taken orally once daily with water on an empty stomach, at least 6 hours after a meal (i.e., after overnight fasting) and at least 1 hour before the next meal. However, in case of intolerability, it can be reduced to 20 mg per day if needed & as soon as adverse reactions resolve, patients should continue on Palsonify 40 mg once daily. After completion of 2 to 4 weeks on 40 mg Palsonify , based on their IGF-1 levels, patients may be directed to raise the dosage to 60 mg once daily.
Finally, Palsonify may increase the risk of gallstones, blood sugar fluctuations (high or low), slow heart rate, thyroid abnormalities, and issues with fat absorption that can lead to steatorrhea or changes in vitamin B12 levels. The most common side effects include diarrhea, abdominal pain, nausea, reduced appetite, slow heart rate, high blood sugar, and stomach inflammation.
As with any medication, patients should be closely monitored and consult their healthcare provider if any concerning symptoms occur.
Learn more: FdaFDA approves new treatment for acromegaly, a rare endocrine disorder
