Srinivas Nalamachu
University of Kansas
Publications 64
#1Richard L. RauckH-Index: 39
#2D. Alexander OhH-Index: 1
Last.Steven JamesH-Index: 1
view all 8 authors...
Background and Objectives Fentanyl sublingual spray may be a viable alternative to intravenous (IV) opioids for the treatment of acute pain. As patients with acute pain may include those who have limited prior exposure to opioids, this phase 1, open-label, randomized, multiple ascending-dose study was conducted to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability of multiple doses of fentanyl sublingual spray in opioid-naive participants. This article primarily reports the ...
1 CitationsSource
Deaths from opioid overdoses have increased dramatically over the past few years. Given that immediate-release (IR) opioids account for most of the U.S. market share, and that abusers generally prefer IR opioids over extended-release (ER) opioids, it is not surprising that rates of abuse are higher for IR than ER opioids. IR opioids are widely prescribed, often without consideration for risks of abuse, misuse, and diversion. Prescription opioid abuse and misuse often begins through oral administ...
1 CitationsSource
Objective: Efficacy and safety of naloxegol, a peripherally acting μ-opioid receptor antagonist that significantly reduces opioid-induced constipation (OIC), were assessed for patient subgroups defined post hoc by baseline maintenance opioid characteristics. Design: Post hoc, pooled analysis of data from two 12-week, randomized, double-blind, placebo-controlled, phase 3 studies. Setting: Two hundred fifty-seven outpatient centers in the United States and Europe. Patients: Patients with noncancer...
#1Srinivas NalamachuH-Index: 17
Last.Robert B. RaffaH-Index: 43
view all 6 authors...
Opioids are a treatment option for a variety of chronic pain conditions. But long-term opioid use can be associated with side effects, including hypogonadism. Opioid-induced hypogonadism (OIhG) is associated with the alteration of the hypothalamic-pituitary-gonadal axis (HPG). In males, hypogonadism can result in erectile dysfunction, reduced libido, fatigue, worsening mood, and increased risk of osteoporosis; in females, it can result in changes in the menstrual cycle and reduced libido, among ...
AbstractObjective: Fentanyl sublingual spray offers rapid pain relief in opioid-tolerant cancer patients, and may be useful in acute or post-operative pain. Both opioid-naive and non-tolerant patients are likely to receive opioids in these settings. Understanding the relationship between systemic exposure of fentanyl sublingual spray and effects on respiratory function in opioid-naive or non-tolerant populations is important to ensure patient safety. This study evaluated single-dose fentanyl sub...
1 CitationsSource
#1Richard L. RauckH-Index: 39
#2John D. MarkmanH-Index: 19
Last.Nathaniel P. KatzH-Index: 50
view all 10 authors...
#1Robert B. Raffa (TU: Temple University)H-Index: 43
Last.Evan T. EdwardsH-Index: 4
view all 6 authors...
The increased use of opioids for chronic treatment of pain and the resulting epidemic of opioid overdoses have created a major public health challenge. Parenteral naloxone has been used since the 1970’s to treat opioid overdose. Recently, a novel naloxone auto-injector device (EVZIO, kaleo, Inc., Richmond, VA) was approved by the Food and Drug Administration. In this article, we review the Human Factors Engineering (HFE) process used in the development and testing of this novel naloxone auto-inj...
7 CitationsSource
#1Charles Argoff (Albany Medical College)H-Index: 25
#2Bill H. McCarberg (UCSD: University of California, San Diego)H-Index: 15
Last.C. YoungH-Index: 7
view all 5 authors...
Objectives. To evaluate opioid rescue medication usage and the opioid-sparing effect of low-dose SoluMatrix® diclofenac developed using SoluMatrix Fine Particle Technology™ in a phase 3 study in patients experiencing pain following bunionectomy surgery. Design. Multicenter, randomized, double-blind, parallel-group study ([NCT01462435][1]). Setting. Four clinical research centers in the United States. Subjects. Four hundred twenty-eight patients aged 18 to 65 years who experienced moderate-to-sev...
2 CitationsSource
#1Thomas BarrettH-Index: 4
Last.Jim L. YoungH-Index: 3
view all 5 authors...
Objectives To characterize the safety of immediate-release (IR)/extended-release (ER) oxycodone (OC)/acetaminophen (APAP). Methods Data were assessed from 9 phase 1 trials in healthy volunteers and recreational users of prescription opioids (N = 405), including 5 single-dose and 3 multidose open-label pharmacokinetic studies of IR/ER OC/APAP and active comparators; and 1 randomized, controlled, single-dose human abuse potential (HAP) study comparing IR/ER OC/APAP, IR OC/APAP, and placebo in recr...
1 CitationsSource