MOVANTIK™ (naloxegol)

Therapeutic Area Nektar
Discovered
Indication Phase Partner
CNS/Pain
MOVANTIK™ (naloxegol) Opioid-induced constipation (OIC)
Phase 3 Completed - Filed in USA, EU and Canada
AstraZeneca
NKTR-119
(Movantik fixed-dose combination product)
Analgesic for pain
Preclinical
AstraZeneca

About Opioid-Induced Constipation
Opioids are commonly prescribed to patients experiencing chronic pain, which can provide relief from serious medical conditions including osteoarthritis, cancer, and chronic back pain.1 There are about 250 million opioid prescriptions written annually in the US alone to treat these conditions.2 Patients taking opioids to treat chronic pain commonly experience a side effect known as opioid-induced constipation, which may include infrequent bowel movements and difficulty passing stools or emptying bowels.1,3 Clinically, OIC is the most prevalent side effect of opioid therapy.4 For those patients who take opiates for long term pain management, studies show that up to 80% of patients experience OIC.5-9 Only about 40-50 percent of those patients experience effective relief from current treatment options.10,11

About MOVANTIK™ (naloxegol)
MOVANTIK is an investigational drug candidate being developed by Nektar partner AstraZeneca for the treatment of opioid-induced constipation in patients with chronic, non-cancer pain. The Prescription Drug User Fee Act (PDUFA) date set by the FDA for MOVANTIK is 16 September 2014. MOVANTIK is also under regulatory review with health agencies in the European Union and Canada.

MOVANTIK is an investigational drug candidate being developed as a once-daily oral tablet for the treatment of opioid-induced constipation. MOVANTIK was designed using Nektar's proprietary small molecule polymer conjugate technology. NKTR-119 is an early stage drug development program that is intended to combine Movantik with selected opioids, with the goal of treating pain without the side effect of constipation traditionally associated with opioid therapy.

Nektar and AstraZeneca have a global agreement for both MOVANTIK and NKTR-119. Under the agreement, AstraZeneca has responsibility for the development, global manufacturing and marketing of both MOVANTIK and NKTR-119. For MOVANTIK, Nektar is eligible to receive up to $235 million in aggregate payments upon the achievement of certain regulatory milestones, as well as additional tiered sales milestone payments of up to $375 million if the product achieves considerable levels of commercial success. Nektar will also be eligible to receive significant double-digit royalty payments on net sales of MOVANTIK worldwide. For NKTR-119, Nektar would receive development milestone payments as well as tiered sales milestone payments. Nektar will also receive significant double-digit royalty payments on NKTR-119 net sales worldwide.

The AstraZeneca Phase 3 KODIAC Program for MOVANTIK™ (naloxegol)
The KODIAC Program consisted of two randomized, placebo controlled Phase III efficacy studies and an open-label, randomized, placebo-controlled long term safety study. The two efficacy studies are identical with 12-week treatment periods. These studies evaluated the efficacy, safety and tolerability of an AstraZeneca investigational drug in patients with OIC. KODIAC is part of the KODIAC program of studies to determine whether MOVANTIK is safe and effective for the treatment of constipation seen as a side effect in people taking prescription opioid pain medications. Results from the study have been published in the June 4, 2014 online edition of the New England Journal of Medicine.

MOVANTIK has been filed for regulatory approvals in the U.S., Europe and Canada as a once- daily, oral tablet for the treatment of opioid-induced constipation.

References

 
1Reimer, K et al. Meeting the challenges of opioid-induced constipation in chronic pain management - a novel approach. Pharmacology. 2009; 83:10-17.
2IMS MAT. December 2010.
3Johanson, JF and Kraltein, J. Chronic constipation: a survey of the patient perspective. Aliment Pharmacol Ther. 2007; 25:599-608.
4Fakata, K. Peripheral Opioid Antagonists: A Therapeutic Advance for Optimizing Opioid Gastrointestinal Tolerability. The Journal of Family Practice. 2007;56:S1-S12.
5Bell TJ, et al., Pain Med 2009;10(1):35-42.
6Hess B, et al., Eur J Intern Med 2011;22(5):527-531.
7Rosti G, et al Eur Rev Med Pharmacol Sci. 2010;14(12):1045-1050.
8Galvez R, et al., Aten Primaria 2014;46(1):32-39.
9Droney J, et al., Support Care Cancer 2008;16(5):453-459.
10Bell, T et al. OBD symptoms impair quality of life and daily activities, regardless of frequency and duration of opioid treatment: results of a U.S. patient survey (PROBE survey). Poster presented at The 25th Annual Scientific Meeting of the American Pain Society. San Antonia, TX, USA.
11Pappagallo, M. Incidence, prevalence, and management of opioid bowel dysfunction. Am J Surg. 2001:182;S11-S18.
 
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