Drug approved for nighttime urination, plus two more

FDA recently approved 3 novel drugs: one to treat frequent urination at night, one to treat carcinoid syndrome diarrhea in cancer patients, and one for dust mite allergies. Here are the details on the 3 new treatments.

1. Desmopressin acetate (Noctiva, Serenity Pharmaceuticals) is the first FDA-approved treatment for adults who awaken at least 1 times per night to urinate due to a condition known as nocturnal polyuria (overproduction of urine during the night).

“Today’s approval provides adults who overproduce urine at night with the first FDA-approved therapeutic option to help reduce the number of times a night they wake up to urinate,” said Hylton V. Joffe, MD, director of the Division of Bone, Reproductive, and Urologic Products in the FDA’s Center for Drug Evaluation and Research, in a FDA statement. “It is important to know that Noctiva is not approved for all causes of night-time urination, so patients should discuss their symptoms with their health care provider who can determine the underlying cause of the night-time urination and whether Noctiva is right for them.”

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Because the nasal spray is approved only for adults with nocturia caused by nocturnal polyuria, healthcare providers should confirm overproduction of urine at night with a 24-hour urine collection, if one has not been obtained previously. “Healthcare providers should also be mindful of underlying conditions that can cause nocturia, but that make treatment with Noctiva unsafe, such as excessive drinking of fluids or symptomatic congestive heart failure,” FDA said.

2. Telotristat ethyl (Zermelo, Lexicon Pharmaceuticals) is the first and only orally administered therapy for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults with inadequately controlled by SSA therapy, according to Lexicon.

The new treatment is available by prescription is available through select specialty pharmacies.

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Carcinoid syndrome is a rare and debilitating condition that affects people with metastatic neuroendocrine tumors (mNETs). Xermelo targets the overproduction of serotonin inside mNET cells , providing a new treatment option for patients suffering from carcinoid syndrome diarrhea.

“Today’s approval of Xermelo represents a shift in the treatment paradigm of carcinoid syndrome diarrhea for cancer patients who are inadequately controlled by SSA therapy, and until now, have had limited options to manage this debilitating condition,” said Lonnel Coats, president and CEO of Lexicon in a statement. “We are proud to have discovered and developed this ground-breaking orphan drug, and it is an honor to make it available for the thousands of patients currently suffering from this condition who wish to lead a more routine life with fewer incidences of severe diarrhea.”

3. Odactra (Catalent Pharmecuticals, Merck) is the first allergen extract to be administered under the tongue to treat house dust mite (HDM)-induced allergic rhinitis, with or without eye inflammation.

“House dust mite allergic disease can negatively impact a person’s quality of life,” said Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research, in a FDA statement. “The approval of Odactra provides patients an alternative treatment to allergy shots to help address their symptoms.”

Odactra exposes patients to house dust mite allergens, gradually training the immune system in order to reduce the frequency and severity of nasal and eye allergy symptoms. It is a once-daily tablet, taken year round, that rapidly dissolves after it is placed under the tongue.

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