Late-stage trial to commence for AstraZeneca’s opioid-induced constipation treatment
WILMINGTON, Del. — Anglo-Swedish drug maker AstraZeneca has enrolled the first patient in a late-stage clinical trial for a drug to treat constipation related to use of opioid painkillers, the company said.
The phase-3 trial will investigate the safety and efficacy of NKTR-118 as a treatment for opioid-induced constipation. It will consist of two 12-week placebo-controlled studies with about 630 patients each, and a long-term safety study that will include patients from the efficacy studies, as well as new patients. AstraZeneca is developing the drug under a license agreement with Nektar Therapeutics.
“This is a key milestone for NKTR-118,” AstraZeneca EVP global medicines development Anders Ekblom said. “We will put our knowledge and our effort into studying NKTR-118 as a potential new treatment option for opioid-induced constipation, which continues to be an area of unmet need in patients needing effective pain treatment.”
Amylin, Takeda suspend obesity drug trial
SAN DIEGO — Amylin Pharmaceuticals and Takeda Pharmaceutical have suspended a mid-stage trial of an obesity drug over safety concerns, the two said Wednesday.
The drug makers stopped the phase-2 trial of a combination of pramlintide and metreleptin due to problems that arose in two patients related to metreleptin. Amylin said the decision to suspend the trial did not affect its investigations of metreleptin as a treatment of diabetes and hypertriglyceridemia in patients with lipodystrophy.
“The safety of patients in our clinical programs is of paramount concern to the companies,” Amylin SVP and chief medical officer Orville Kolterman said. “We have taken this precaution so that we can thoroughly investigate this finding.”
Fleming responds to nuclear crisis by boosting production of ThyroShield
ST. LOUIS — Drug maker Fleming Pharmaceuticals is increasing production of a drug for preventing thyroid cancer in response to the nuclear crisis in Japan.
The drug, ThyroShield (potassium iodide), is designed for use in nuclear emergencies and works by saturating the thyroid gland so that it can’t absorb radioactive iodine.
“ThyroShield is not routinely stocked in large quantities, but we are putting a plan in place that expedites production and delivery,” Fleming Pharmaceuticals president Phill Dritsas said. “However, in the case of Japan, we simply don’t have enough inventory to even begin to fill a need that great and immediate.”
State and local governments are required to provide potassium iodide medicine to citizens living within 20 miles of the country’s 104 nuclear power plants, and the federal government has stockpiled millions of doses for governments to distribute.
“Some of the nation’s stockpile of ThyroShield has already expired, and the remaining inventory will expire over the next year and a half,” Dritsas said. “If federal officials were to decide to donate the existing medicine, while it is still viable, for humanitarian efforts in Japan, that could address the immediate need there and give us time to accelerate production here and work with the federal government to replenish what was donated.”