Acromegalic patients need oral medication option for improved quality of life
- by: Susan Ambrozich
- recipient: US Food and Drug Administration
Currently the only medical alternative to this chronic, systemic disease is injectable medication that is administered by health care providers (i.e. not self administered). Untreated, this disease is terminal. This tumor on the master gland is often inoperable, and frequently even with surgery patients require on-going painful injections. These injections require patients to go to their provider (oftentimes, a long distance), run the risk of the large needle and gauge getting clogged with the thick medication. The medication requires refrigeration, specific unique preparation and room temperature a half hour before injections. They are usually painful, inconvenient (tethered to the clinic, transportation, confirmation that that was ordered and delivered in time, a skilled and trained care giver, additional needles in the event of needing to re-stick, etc.). Additionally, these injections do not prevent "break through" symptoms.
The oral formulation is of the same medication that has been approved and shown to be effective in stabilizing patients- albeit with a new manner (TPE) of taking the medication using two oral capsules twice a day (on an empty stomach). The third trials of this medication proved that it is a safe and effective alternative to injections. Mycappsa would improve the quality of lives, as the 86% of subjects volunteered to continue using the medication (i.e. despite the rigors of participating in the study).
Petition to the FDA for Approval of Oral Octreotide for Acromegaly
Petition Summary: Oral Octreotide (Mycappsa™) is a much needed treatment option for Acromegaly patients. Current treatment options do not provide adequate control of the disease or improved quality of life for many patients diagnosed with Acromegaly.
Action Petitioned For: We, the undersigned patients, friends, and/or family members, with all due respect to the Food and Drug Administration, appeal the rejection of Mycappsa™ for the chemical management of the chronic disease, acromegaly. We request reconsideration of the Agency’s denial of oral octreotide, respectfully disagreeing with the Agency’s conclusions that Chiasma’s application failed to provide substantial evidence of efficacy to warrant approval. We, as patients and supporters, have experienced the difficulties associated with acromegaly and the inherent insufficiency, pain, and inconvenience associated with injectable medications. The oral format, Mycappsa™ (octreotide acetate), would provide patients with an alternative method for treatment and maintenance, that would dramatically improve the quality of life for patients without the risks of a new formulation. Mycappsa™, an oral form of injectable octreotide, has been shown to be extremely effective in acromegaly treatment while alleviating the burden, pain, and decreased quality of life resulting from regular somatostatin analogue injections. Furthermore, this oral treatment option allows acromegaly patients who suffer from debilitating “breakthrough symptoms” between injections to improve their quality of life through daily dosing and consistent intake. We also understand that there were no safety concerns considered with this trial. In the third phase, 86% of patients who were in the trial had voluntarily chosen to remain on Mycappsa™, further substantiating its effectiveness. Current treatments must be kept refrigerated (up to a half hour before injections) to maintain effectiveness of treatment. Mycappsa™ alleviates this need, which also supports an improved quality of life.
Please consider our sincere appeals that this rejection decision is overturned and the request for approval is reconsidered
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