Monday, June 18, the agency will make a decision on Ortho Dermatologics’ New Drug Application (NDA) for IDP-118 lotion for plaque psoriasis. On June 13th, SCPharmaceuticals received a CRL for its Furoscix infusor.
Monday, June 18, the agency will make a decision on Ortho Dermatologics’ New Drug Application (NDA) for IDP-118 (halobetasol propionate and tazarotene) lotion for plaque psoriasis. Ortho is a division of Laval, Quebec’s Valeant Pharmaceuticals International.
If approved, it will the first and only topical lotion containing the combination of the two compounds in one formulation. Both compounds are already approved to treat plaque psoriasis separately, but are limited to four weeks or less of treatment. The data accumulated suggests that because of the dual mechanism of action, IDP-118 might be able to be used for a longer period of time with reduced side effects.
The company submitted the NDA in September 2018. It was based on data from two Phase III multi-center, randomized, double-blind clinical trials in 418 patients 18 years of age or older who had three to 12 percent of their body surface affected by plaque psoriasis. In both trials, the compound met the primary efficacy endpoint of “clear” to “almost clear” score at least a 2-grade improvement based on an Investigator Global Assessment (IGA) at eight weeks, and a “clear” to “almost clear” and at least a 2-grade improvement during a four-week follow-up visit at week 12. The NDA also had data from a long-term safety study involving patients followed up after a year.
“We are greatly encouraged by the efficacy and safety results of the IDP-118 clinical program and proud of the dedication of our medical and R&D teams who were able to expedite the NDA filing ahead of internal expectations for this promising treatment,” said Joseph Papa, Valeant’s chairman and chief executive officer in a statement in September. “This submission reflects our unwavering commitment to investing in our pipeline to bring forward novel treatment innovations that help improve the lives of our customers and their patients.”
The agency was scheduled to decide on scPharmaceuticals’ NDA for its Furoscix infusor (furosemide) 80 mg/10mL, drug-device combination. However, on May 31, SCPharma, located in Burlington, Massachusetts, reported that the FDA, as part of its ongoing review of the NDA, had noted “deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time. The letter further states that the notification does not reflect a final decision on the information under review.”
Then, on June 13, the company received a Complete Response Letter (CRL). The CRL informed the company it needed additional human factors studies, device modifications, and potentially a clinical validation study. SCPharma indicated it plans to meet with the agency to “further evaluate the deficiencies raised.”
John Tucker, company president and chief executive officer, said in a statement, “While we are disappointed with the outcome of the review, we are committed to addressing the issues of the CRL and bringing this important product to market. Our team will continue to work closely with the FDA to determine an appropriate path forward regarding product performance, appropriate patient identification, and risk mitigation strategies that ultimately enable a timely resubmission of the Furoscix NDA.”
Furoscix is the company’s subcutaneous formulation of furosemide delivered by way of the company’s patented sc2Wear Infusor to treat worsening, or decompensated, heart failure outside of the inpatient setting. The NDA was filed in August 2017. On October 2017, the FDA accepted the application for review.
The company stated in a filing with the U.S. Securities and Exchange Commission (SEC), “Our novel formulation of furosemide was designed for subcutaneous delivery with a physiologic pH level to avoid the burning and discomfort associated with subcutaneous delivery of the current alkaline IV furosemide formulation. Foroscix consists of this novel formulation of furosemide for subcutaneous administration with our wearable, portable sc2Wear Infusor for the treatment of edema in patients with heart failure. Furoscix is delivered subcutaneously and has been observed in our clinical studies to date to provide comparable diuresis to IV furosemide with good tolerability.”
