Intercept Pharmaceuticals Inc (NASDAQ:ICPT) management hosted a conference call this morning to address Ocaliva safety concerns. As a reminder, company issued a Healthcare Provider letter on 9/12/17 and FDA issued a Drug Safety Communication on 9/21/17 regarding reports of patient deaths and liver injury. Safety concerns revolve primarily around appropriate Ocaliva dose in patients with moderate-severe decreased liver function. A number of patients were reportedly administered 5mg daily Ocaliva instead of labelled 5mg weekly.
- Label Recommended Ocaliva Dosing – Recommended dosing in the label for Ocaliva in earlier stage PBC patients with no or mild hepatic impairment (non-cirrhotic or Child-Pugh A cirrhosis) starts at 5 mg once daily, increasing after three months to 10 mg once daily based on tolerability and treatment response. However, in late stage patients with moderate or severe hepatic impairment (Child Pugh B or C cirrhosis), recommended dosing starts at 5 mg once weekly, with the possibility to gradually increase to a maximum of 10 mg twice weekly. The reason for this less frequent dosing is that systemic and hepatic concentrations of Ocaliva are predicted to significantly increase in such patients and dose-related liver adverse reactions have previously been documented in PBC patients participating in clinical trials.
- Recently Issued Dear Healthcare Provider Letter and FDA Safety Communication – In the course of Intercept’s post-marketing pharmacovigilance activities, deaths have been reported in PBC patients with moderate or severe hepatic impairment (Child Pugh B or C cirrhosis). In an analysis performed by Intercept and in consultation with the FDA, Intercept concluded that these patients were prescribed once daily doses of Ocaliva, which is seven times higher than the recommended weekly dose in such patients. As a result, Intercept issued the DHCP letter and the FDA subsequently issued their own safety communication to reinforce recommended label dosing. Both communications remind healthcare providers of the importance of the recommended reduced dosing of Ocaliva in PBC patients with moderate or severe hepatic impairment (Child Pugh B or C cirrhosis), while reiterating the importance of close monitoring of PBC patients for progression of their disease and the occurrence of liver-related adverse reactions.
Most of the Street remains unfazed by the warning letters, as TipRanks analytics exhibit ICPT as a Buy. Out of 14 analysts polled by TipRanks in the last 3 months, 7 are bullish on Intercept stock while 5 remain sidelined, and 2 are bearish. With a return potential of 142%, the stock’s consensus target price stands at $151.45.
IntelliPharmaCeutics Intl Inc (USA) (NASDAQ:IPCI) announced today that it has received a complete response letter from the FDA for the New Drug Application (NDA) seeking approval of Rexista for the treatment of moderate to severe pain. The complete response letter indicates recommendations and requests for information, including: (1) That Intellipharmaceutics complete the relevant Category 2 and Category 3 studies to assess the abuse-deterrent properties of Oxycodone ER by the oral and nasal routes of administration. (2) The FDA also requested additional information related to the inclusion of the blue dye in the Oxycodone ER formulation, which is intended to deter abuse.
“The FDA’s response clarifies our path forward for Oxycodone ER”. said, Isa Odidi, CEO of Intellipharmaceutics. “We had already planned the additional Category 2 and Category 3 studies the FDA has requested and we do not expect they will impact our anticipated commercialization timeline for Oxycodone ER.”
Odidi concluded, “We will continue to work closely with the FDA to provide them with the additional information they requested, including data supporting the label claims related to Oxycodone ER’s abuse-deterrent properties. We believe our Oxycodone ER product can play an important preventative role in the midst of a serious opioid abuse crisis particularly impacting North America. The company will be providing regular updates as we execute on our Oxycodone ER NDA resubmission plan.”