|Nektar Issues Data from NKTR-181; CryoLife Receives Conditional IDE Approval|
|By Staff and Wire Reports|
|Wednesday, 19 June 2013 18:45|
Nektar Therapeutics (Nasdaq: NKTR) announced positive top-line results from a human abuse liability (HAL) study for NKTR-181, a first-in-class, opioid analgesic molecule with a slow rate of entry into the brain. This slow rate of entry is designed to reduce the euphoria that can lead to the abuse of and addiction to current opioid analgesics.1 In the study data being presented today, NKTR-181 was rated similar to placebo in "drug liking" and "feeling high" scores and had highly statistically significant lower "drug liking" scores and reduced "feeling high" scores as compared to oxycodone at all doses tested (p<0.0001).
Prescription opioids are critical in the management of moderate-to-severe chronic pain. However, the abuse and misuse of these opioids have led to a serious public health crisis. HAL studies are clinical studies that assess the relative abuse potential of a medicine. These studies are conducted in a non-dependent, recreational drug abuser population and are designed to predict how probable it is that a particular medicine will be attractive to abusers (i.e., "liked"). The primary endpoint for the NKTR-181 HAL study was drug-liking measured on a bi-polar visual analogue scale (VAS). This endpoint is known to correlate most directly with a drug's potential for abuse.^2
"It is clear that there is a pressing societal need for better and safer analgesics," said Dr. Lynn Webster, President of the American Academy of Pain Medicine and lead investigator for the study at CRI Lifetree. "We know that speed of entry into the brain is important in abuse. When we look at the critical period following dosing when the commonly abused drug oxycodone reaches maximum liking, NKTR-181 was not distinguished from placebo with respect to both drug-liking and feeling high. These are two of the most important metrics that help us understand the abuse potential of a medicine. Importantly, NKTR-181 was dosed as an oral liquid, which underscores that its less rewarding properties are inherent to this NCE and independent of any abuse-deterrent formulation. These data, along with previous efficacy data, suggest NKTR-181 may be a major advance towards safer opioid therapy for the treatment of moderate to severe chronic pain."
The HAL study compared drug liking between each treatment group (oxycodone 40 mg, Placebo, and NKTR-181 100 mg, 200 mg, and 400 mg). On the bipolar VAS scale (0-100), a score of 50 indicates that the subject "neither likes nor dislikes" the drug. In the study, 40 mg of oxycodone oral solution resulted in a maximum mean drug liking score of 85, indicating a "strong liking" for the effects of oxycodone. The oxycodone liking score was significantly different from placebo as early as 15 minutes after dosing and peaked at 60 minutes. In the placebo arm, the maximum mean drug liking score was 50, indicating that the subjects neither liked nor disliked the effects. NKTR-181 dosing was similar to placebo with maximum mean drug liking VAS scores of 58, 58 and 63 for 100 mg, 200 mg and 400 mg, respectively.
"The data from this study are remarkable and clearly demonstrate that drug abusers could not discriminate NKTR-181 from placebo at doses that we know produced analgesia in the validated pain models from our Phase 1 studies," said Robert Medve MD, SVP and Chief Medical Officer of Nektar Therapeutics. "These data suggest that NKTR-181 could change the way we think about opioids and how we treat patients with chronic pain."
CryoLife (NYSE: CRY), a leading tissue processing and medical device Company focused on cardiac and vascular surgery, announced it has received conditional approval of its Investigational Device Exemption (IDE) for PerClot from the United States Food and Drug Administration (FDA).
PerClot is a unique hemostat composed of absorbable polysaccharide granules and is intended for use in surgical procedures as an adjunctive hemostatic device when control of capillary, venular, and arteriolar bleeding by pressure, ligature, and other conventional means is ineffective or impractical. PerClot has CE Mark designation and CryoLife began distributing PerClot in several international markets in the fourth quarter of 2010. PerClot international sales were up 34 percent in the first quarter of 2013 compared to the first quarter of 2012.
"We're pleased to reach this initial milestone toward the commercialization of PerClot in the U.S.," stated Steven G. Anderson, CryoLife president and chief executive officer. "Subject to satisfaction of the FDA's conditions, we plan to begin enrollment in the pivotal trial in the third quarter of 2013, and hope to have pre-market approval in 2015."
The U.S. hemostatic market is estimated to be $889 million in 2012 growing to approximately $1.1 billion in 2014, while the European market is estimated to be $361 million in 2012 growing to approximately $430 million in 2014.
The PerClot IDE is a prospective, multicenter, multidisciplinary, controlled clinical investigation. The primary objective of this investigation will be to collect clinical data concerning the safety and efficacy of PerClot versus a similar marketed hemostatic device in multiple surgical disciplines when used as an adjunct to conventional means of achieving hemostasis such as pressure or ligature. The primary efficacy endpoint of this investigation will be achievement of hemostasis at the site of application at 5 minutes following application of the prescribed hemostatic agent. The secondary efficacy endpoint for this investigation will be hemostasis at the site of application evaluated at 2 minutes. Safety endpoints will include, but are not limited to, the incidence of reoperation due to bleeding, total hospitalization and procedure time, and the incidence of procedure complications and/or adverse events through final patient follow-up.
As part of the conditional approval for the PerClot IDE, CryoLife must make certain revisions to the investigational study protocol, clinical product labeling and Patient Informed Consent forms. The Company anticipates refiling the IDE submission in July. The Company expects to begin enrollment in the general and urological surgical cohorts during the third quarter. The Company will have further discussions with the FDA to clarify the requirements prior to enrollment in the cardiac and orthopedic indications.
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