MedPath

Octreotide

Generic Name
Octreotide
Brand Names
Bynfezia, Mycapssa, Sandostatin
Drug Type
Biotech
CAS Number
83150-76-9
Unique Ingredient Identifier
RWM8CCW8GP
Background

Acromegaly is a disorder caused by excess growth hormone (GH), increasing the growth of body tissues and causing metabolic dysfunction. In most cases, it results from an anterior pituitary growth hormone-releasing tumor. Typically, the feet, hands, and face grow abnormally large; organomegaly and insulin resistance may also occur. Acromegaly is a life-threatening disease requiring life-long management.

Octreotide is a long-acting drug with pharmacologic activities that mimic those of the natural hormone, somatostatin, which inhibits the secretion of growth hormone. Additionally, it is used for the treatment of acromegaly and symptoms arising from various tumors, including carcinoid tumors and vasoactive intestinal tumors (VIPomas). In the past, octreotide has been administered solely by injection. On June 26, 2020, the first approved delayed-release oral somatostatin analog, Mycapssa, received FDA approval for the long term maintenance treatment of acromegaly. This drug was developed by Chiasma Inc.

Indication

Octreotide by injection is used for the treatment of acromegaly and the reduction of flushing and diarrhea symptoms related to carcinoid tumors and/or vasoactive intestinal peptide (VIPoma) tumors. The delayed-release oral formulation is used for the long-term treatment of acromegaly in patients who tolerate and respond adequately to injectable octreotide and lanreotide.

Associated Conditions
Acromegaly, Diarrhea, Metastatic Carcinoid Tumors
Associated Therapies
Long-term maintenance therapy

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• The FDA issued a Complete Response Letter (CRL) for Camurus' CAM2029 (octreotide) extended-release injection for acromegaly due to manufacturing deficiencies. • The CRL is linked to a third-party manufacturer's cGMP inspection in September 2024, with no concerns about CAM2029's clinical efficacy or safety. • Camurus is collaborating with the FDA and the manufacturer to address the issues and expedite the drug's availability for acromegaly patients. • A Market Authorization Application for CAM2029 is under review in the EU, and development programs for other indications are ongoing.

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FDA Issues Complete Response Letter for Camurus' Acromegaly Drug CAM2029

• The FDA issued a Complete Response Letter (CRL) for Camurus' CAM2029, an extended-release octreotide injection, intended for treating acromegaly, citing manufacturing deficiencies. • The CRL was prompted by issues identified during a Current Good Manufacturing Practices (cGMP) inspection at a third-party manufacturing facility. • Camurus is collaborating with the FDA and the third-party manufacturer to address the identified deficiencies and resolve the issues for CAM2029 approval. • CAM2029's European Union market authorization application remains under review, and its development for other indications is ongoing, unaffected by the FDA's decision.

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FDA Accepts Camurus' NDA for Oclaiz™ (CAM2029) in Acromegaly Treatment

• The FDA has accepted Camurus' New Drug Application (NDA) for Oclaiz™ (CAM2029) for treating acromegaly, setting a PDUFA target action date of October 21, 2024. • Oclaiz™ is a novel, once-monthly subcutaneous depot formulation of octreotide designed for convenient self-administration and enhanced drug exposure. • The NDA is supported by data from seven clinical studies, including two Phase 3 trials within the ACROINNOVA program, demonstrating superior biochemical control compared to placebo. • Camurus aims to provide an effective treatment option for acromegaly patients, potentially reducing treatment burden and improving their quality of life.
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