Dive Brief:
- On March 3, Serenity Pharmaceutical’s Noctiva (desmopressin acetate), a metered nasal spray, became the first therapeutic option approved by the Food and Drug Administration for adults who awaken at least two times per night to urinate due to nocturnal polyuria, a condition causing overproduction of urine during the night.
- Yet, the FDA stressed that the drug, a vasopressin analog — which will be marketed with a boxed warning and a medication guide because it can cause low sodium levels in the blood (hyponatremia) — is not approved for all causes of night-time urination. In fact, it is contraindicated for children, pregnant women, patients with symptomatic congestive heart failure or uncontrolled hypertension, and others.
- Pennsylvania-based Serenity declined to discuss pricing for Noctiva (SER-120), but it may be positioning the drug, which has been on the market four decades for other indications, for a hefty pricetag.
Dive Insight:
Serenity said in a statement to BioPharma Dive: “We are pleased the FDA recognized the unmet need facing patients with nocturia and approved Noctiva (desmopressin acetate) nasal spray as the first treatment for this condition. We worked closely with the FDA and the medical community to develop this important new medication, and we look forward to bringing it to patients in the near future.”
Yet the FDA noted that there are other FDA-approved medications also containing desmopressin, though none are approved to treat nocturia. In fact, the drug has been on the market since the mid-1970s for a wide variety of uses, including diabetes insipidus, bedwetting and prevention of bleeding in patients with hemophilia A.
Ferring Pharmaceuticals, the original developer of desmopressin, acquired an oral version and nasal spray formulation under the name DDAVP from Sanofi in 2014.
Subsequently, Ferring failed in its own efforts to land the FDA’s approval for Nocdurna, desmopressin in tablet form, to treat nocturnal polyuria – though the Swiss-based company has gotten the green light for selling the drug to treat nocturia in dozens of other countries. When an FDA advisory panel voted against Nocdurna in January 2015, it said the main safety issue associated with Nocdurna’s use in the elderly nocturia population was risk of hyponatremia, noting patients continued to have mild hyponatremia despite monitoring.
In October 2016, an FDA advisory panel recommended that the agency approve Noctiva for nocturnal polyuria. Late that year, Ferring filed a citizen petition asking FDA to hold Serenity's drug to the same standards as Nocdurna.
In approving Noctiva, the FDA said the drug’s efficacy for treating nocturnal polyuria was established in two placebo-controlled studies. But the agency included a long list of safety caveats.
At the end of its announcement on Noctiva’s FDA approval, Serenity noted that it and Allergan have agreed to terminate their global agreement for the development and commercialization of Noctiva following a 90-day transition period. "Moving forward, Serenity will be responsible for commercialization and continued development of the product," the company said.
"The mutual termination of its global development and commercialization agreement for Noctiva (SER-120) was due to a shift in Allergan’s commercial priorities. We wish Serenity well in the commercialization of Noctiva for this unmet medical need," said Allergan, which had partnered with Serenity on SER-120 since 2010, in a statement to BioPharma Dive.
Noctiva is being manufactured for Serenity by Pennsylvania-based Renaissance Lakewood, the FDA said.