RICHMOND, Va. - Indivior PLC (NASDAQ:LSE: INDV), a pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review for a Prior Approval Supplement (PAS) for SUBLOCADE® (buprenorphine extended-release) injection. The PAS submission seeks to expand the label of SUBLOCADE to include alternative injection sites and a rapid induction protocol, potentially addressing unmet needs for patients and healthcare providers in the treatment of opioid use disorder (OUD).
The proposed label updates would allow the medication to be administered subcutaneously not only in the abdomen but also in the thigh, buttock, and back of the upper arm. Additionally, the new protocol could reduce the induction time from seven days to one hour after a single transmucosal buprenorphine dose, with the possibility of administering a second 300 mg dose as early as one week after the initial injection, depending on patient needs.
Indivior's submission is backed by comprehensive data that the company believes demonstrate the safety and efficacy of SUBLOCADE when used with the new rapid induction protocol and at alternative injection sites. The Priority Review designation signifies that the FDA will aim to complete its review within six months, as opposed to the standard ten-month review.
SUBLOCADE is currently indicated for the treatment of moderate to severe OUD in patients who have initiated treatment with a buprenorphine-containing product, followed by dose adjustment for a minimum of seven days. It is designed to be used as part of a complete treatment plan that includes counseling and psychosocial support.
The medication carries a boxed warning regarding the risk of serious harm or death if administered intravenously and is available only through a restricted program called the SUBLOCADE REMS Program due to these risks. The most common side effects associated with SUBLOCADE include constipation, headache, nausea, injection site itching, vomiting, increased hepatic enzymes, fatigue, and injection site pain.
The FDA's decision on the PAS is expected by February 7, 2025. If approved, these label expansions could offer significant improvements in the treatment of OUD with SUBLOCADE.
This news article is based on a press release statement from Indivior PLC.
In other recent news, Indivior PLC has been the subject of several significant developments. The pharmaceutical company's stock price target was reduced by Craig-Hallum from $24.00 to $20.00, though the firm maintained its Buy rating on the company's stock. The adjustment came amid a reassessment of Indivior's financial projections. On the other hand, Piper Sandler held an Overweight rating on the company's stock, emphasizing the long-term growth potential of Sublocade, Indivior's product for treating opioid addiction.
Indivior also secured an $8.7 million order from the Biomedical Advanced Research and Development Authority (BARDA) for OPVEE®, a medication designed to reverse opioid overdoses. This procurement is set to bolster emergency response capabilities amid the ongoing opioid crisis.
Despite facing challenges such as Medicaid-related issues and new market competition, Indivior's management anticipates Sublocade to grow its net revenue by 25% year over year. Both Craig-Hallum and Piper Sandler expressed belief in the company's resilience and potential growth. These are recent developments investors should consider when evaluating Indivior's financial health.
InvestingPro Insights
As Indivior PLC (NASDAQ:LSE: INDV) awaits the FDA's decision on its SUBLOCADE label expansion, investors may find additional context in the company's financial metrics and market performance. According to InvestingPro data, Indivior's market capitalization stands at $1.33 billion, reflecting its position in the pharmaceutical industry.
The company's revenue growth of 14.47% over the last twelve months and 8.33% in the most recent quarter suggests ongoing demand for its products, including SUBLOCADE. This growth aligns with the potential market expansion that could result from the FDA's approval of alternative injection sites and a rapid induction protocol.
InvestingPro Tips highlight that Indivior's net income is expected to grow this year, and analysts predict the company will be profitable. These projections could be influenced by the anticipated label expansion for SUBLOCADE, which may drive increased adoption and sales.
However, investors should note that the stock has taken a significant hit over the last six months, with a price total return of -51.74%. This decline may present both risks and potential opportunities for investors, depending on the outcome of the FDA review and the company's ability to capitalize on the proposed label changes.
For those seeking a more comprehensive analysis, InvestingPro offers 11 additional tips for Indivior, providing a deeper understanding of the company's financial health and market position.
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