As shared in Medscape, the FDA recently approved oral octreotide (Mycapssa) for the treatment of patients with acromegaly. These delayed-release capsules are the first approved oral somatostatin analog ever approved. Now, patients with acromegaly have the option for less challenging and time-consuming therapeutic options. Prior to this, treatments included injections or removing the pituitary tumor or gland.
According to Acromegaly Community president Jill Sisco, there has long been a huge demand for oral therapeutics to treat this condition. Now, patients who responded well to octreotide or lanreotide injections can instead take up to 80mg of Mycapssa daily.
The FDA’s approval depended on data from the Phase 3 CHIASMA OPTIMAL trial. In the trial, researchers examined 56 patients with acromegaly over a 9-month period. Patients were split into 2 groups and given either oral octreotide (40-80mg) or a placebo.
Ultimately, data from the trial was extremely promising. While only 19% of patients taking the placebo maintained normal growth factor status, 58% of patients taking octreotide did. Additionally, although some patients experienced side effects such as low B12 levels, hyperglycemia, and issues with thyroid function, Mycapssa was found to be well-tolerated and safe.
Once the FDA approves a supplement to the approved NDA, Mycapssa should be available for treatment at the end of 2020.
Acromegaly is a hormonal disorder in which someone has an excess amount of growth hormone (GH). Growth hormone is produced by the pituitary gland and by adenomas, noncancerous tumors. As a result, patients experience an abnormal amount of growth. Around 60 out of every 1 million people have acromegaly.
- An enlarged nasal bone
- A protruding brow and lower jaw
- Enlarged facial features (tongue, vocal chord, lips)
- Joint pain and stiffness
- Organ inflammation and enlargement
- Oily skin
- Excessive sweating
- Abnormal hand and foot growth
Without treatment, acromegaly can result in severe illness or death. As a result, if experiencing symptoms, patients should see their doctors as soon as possible. Learn more about acromegaly.