NEW YORK and JERUSALEM, June 28 /PRNewswire/ -- Chiasma, Inc., a privately held biopharma company, announced that the Food and Drug Administration (FDA) has granted orphan drug designation for Chiasma's investigational new drug, Octreolin, an oral form of octreotide acetate that uses the Company's proprietary Transient Permeability Enhancer (TPE) technology for the oral treatment of acromegaly, a hormonal disorder that results from an excess of growth hormone.
If a New Drug Application (NDA) is approved, Octreolin should qualify for seven years of market exclusivity, potential tax credits, and a waiver of the prescription drug user fee for the marketing application.
Chiasma has successfully completed a Phase I clinical study evaluating the safety and pharmacokinetics (PK) of Octreolin, which demonstrated a PK profile similar to that of subcutaneously injected octreotide acetate. In addition, no serious adverse safety events were reported for Octreolin. The Company intends to initiate a pivotal (Phase 3) trial by the end of the year for Octreolin in acromegaly.
Chiasma will submit an application for Orphan Medicinal Product Designation to the European Medicines Agency (EMA) shortly. The Company intends to submit an NDA using the "505(b)(2) regulatory pathway" in the United States and its equivalent, the "Hybrid Application," in Europe.
Octreolin would provide patients with the benefit of an oral alternative to the currently approved subcutaneous and intramuscular injections. The pool of patients eligible for Octreolin treatment for acromegaly is estimated to be between 10,000 and 15,000 in the U.S. and an equal number in Eur
SOURCE Chiasma, Inc.
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